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|After Burn Double Strength Gel Topical

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ANESTHETICS (Topical)

Some commonly used brand names are:

In the U.S.—

Almay Anti-itch Lotion ⁷
Americaine Topical Anesthetic First Aid Ointment ¹
Americaine Topical Anesthetic Spray ¹
Butesin Picrate ³
DermaFlex ⁵
Dermoplast ²
Lagol ¹
Nupercainal Cream ⁴
Nupercainal Ointment ⁴
Pontocaine Cream ⁸
Pontocaine Ointment ⁹
Pramegel ⁷
Prax ⁶
Tronothane ⁶
Xylocaine ⁵

In Canada—

After Burn Double Strength Gel ⁵
After Burn Double Strength Spray ⁵
After Burn Gel ⁵
After Burn Spray ⁵
Alphacaine ⁵
Dermoplast ²
Endocaine ¹
Norwood Sunburn Spray ⁵
Nupercainal Ointment ⁴
Pramegel ⁷
Shield Burnasept Spray ¹
Tronothane ⁶
Xylocaine ⁵

Other commonly used names are: Amethocaine Butyl aminobenzoate Cinchocaine Ethyl aminobenzoate Lignocaine Pramocaine

Note:

For quick reference, the following anesthetics are numbered to match the corresponding brand names.

This information applies to the following medicines:
1.	Benzocaine (BEN-zoe-kane)‡
2.	Benzocaine and Menthol (BEN-zoe-kane and MEN-thol)
3.	Butamben (byoo-TAM-ben)
4.	Dibucaine (DYE-byoo-kane)‡
5.	Lidocaine (LYE-doe-kane)‡
6.	Pramoxine (pra-MOX-een)
7.	Pramoxineand Menthol (pra-MOX-een and MEN-thol)
8.	Tetracaine (TET-ra-kane)
9.	Tetracaineand Menthol (TET-ra-kane and MEN-thol)†
† Not commercially available in Canada
‡ Generic name product may be available in the U.S.

Description

This medicine belongs to a group of medicines known as topical local anesthetics (an-ess-THET-iks) . Topical anesthetics are used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, and minor cuts and scratches.

Topical anesthetics deaden the nerve endings in the skin. They do not cause unconsciousness as do general anesthetics used for surgery.

Most topical anesthetics are available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

These medicines are available in the following dosage forms:

Topical
Benzocaine
- Cream (U.S.)
- Ointment (U.S.)
- Topical aerosol (U.S.)
- Topical spray solution (Canada)
Benzocaine and Menthol
- Lotion (U.S.)
- Topical aerosol solution (U.S. and Canada)
Butamben
- Ointment (U.S.)
Dibucaine
- Cream (U.S.)
- Ointment (U.S. and Canada)
Lidocaine
- Film-forming gel (U.S.)
- Jelly (Canada)
- Ointment (U.S. and Canada)
- Topical aerosol (Canada)
- Topical spray solution (Canada)
Pramoxine
- Cream (U.S. and Canada)
- Lotion (U.S.)
Pramoxine and Menthol
- Gel (U.S. and Canada)
- Lotion (U.S.)
Tetracaine
- Cream (U.S.)
Tetracaine and Menthol
- Ointment (U.S.)

Before Using This Medicine

If you are using this medicine without a prescription, carefully read and follow any precautions on the label. For topical anesthetics, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to a local anesthetic, especially when applied to the skin or other areas of the body. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes, especially aminobenzoic acid (also called para-aminobenzoic acid [PABA]), to parabens (preservatives in many foods and medicines), or to paraphenylenediamine (a hair dye).

Pregnancy—Although studies on effects in pregnancy have not been done in humans, topical anesthetics have not been reported to cause problems in humans. Lidocaine has not been shown to cause birth defects or other problems in animal studies. Other topical anesthetics have not been studied in animals.

Breast-feeding—Topical anesthetics have not been reported to cause problems in nursing babies.

Children—Benzocaine may be absorbed through the skin of young children and cause unwanted effects. There is no specific information comparing use of other topical anesthetics in children with use in other age groups, but it is possible that they may also cause unwanted effects in young children. Check with your doctor before using any product that contains a topical anesthetic for a child younger than 2 years of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical anesthetics in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of topical anesthetics. Before using a topical anesthetic, check with your health care professional if you have any other medical problems, especially:

Infection at or near the place of application or
Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased

Proper Use of This Medicine

For safe and effective use of this medicine:

Follow your doctor"s instructions if this medicine was prescribed.
Follow the manufacturer"s package directions if you are treating yourself.
Unless otherwise directed by your doctor, do not use this medicine on large areas, especially if the skin is broken or scraped. Also, do not use it more often than directed on the package label, or for more than a few days at a time . To do so may increase the chance of absorption through the skin and the chance of unwanted effects. This is especially important when benzocaine is used for children younger than 2 years of age.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present . This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Read the package label very carefully to see if the product contains any alcohol. Alcohol is flammable and can catch on fire. Do not use any product containing alcohol near a fire or open flame, or while smoking. Also, do not smoke after applying one of these products until it has completely dried .

If you are using this medicine on your face, be very careful not to get it in your eyes, mouth, or nose . If you are using an aerosol or spray form of this medicine, do not spray it directly on your face. Instead, use your hand or an applicator (for example, a sterile gauze pad or a cotton swab) to apply the medicine.

For patients using butamben :

Butamben may stain clothing and discolor hair. It may not be possible to remove the stains. To avoid this, do not touch your clothing or your hair while applying the medicine. Also, cover the treated area with a loose bandage after applying butamben, to protect your clothes.

To use lidocaine film-forming gel (e.g., DermaFlex):

First dry the area with a clean cloth or a piece of gauze. Then apply the medicine. The medicine should dry, forming a clear film, after about 1 minute.

Dosing—The dose of a topical anesthetic will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For benzocaine and for benzocaine and menthol combination
For topical dosage forms (aerosol solution, cream, lotion, ointment, and spray solution):
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed.
  - Children younger than 2 years of age—Dose must be determined by your doctor.

For butamben
For topical dosage form (ointment):
- For pain and itching caused by minor skin conditions:
  - Adults—Apply to the affected area three or four times a day as needed.
  - Children—Dose must be determined by your doctor.

For dibucaine
For topical cream dosage form:
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
For topical ointment dosage form:
- For pain and itching caused by minor skin conditions:
  - Adults—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a twenty-four-hour period is 30 grams, but much smaller amounts are usually enough.
  - Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7.5 grams in a twenty-four-hour period.
  - Children up to 2 years of age—Dose must be determined by your doctor.

For lidocaine
For topical dosage forms (aerosol solution, film-forming gel, jelly, ointment, and spray solution):
- For pain and itching caused by minor skin conditions:
  - Adults—Apply to the affected area three or four times a day as needed.
  - Children—Dose must be determined by your doctor.

For pramoxine and for pramoxine and menthol combination
For topical dosage forms (cream, gel, and lotion):
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed.
  - Children younger than 2 years of age—Dose must be determined by your doctor.

For tetracaine and for tetracaine and menthol combination
For topical dosage forms (cream and ointment):
- For pain and itching caused by minor skin conditions:
  - Adults and teenagers—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a twenty-four-hour period is 30 grams (a whole tube of the medicine), but much smaller amounts are usually enough.
  - Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7 grams (about one-fourth of a tube of the medicine) in a twenty-four-hour period.
  - Children younger than 2 years of age—Dose must be determined by your doctor.

Missed dose—If your doctor has ordered you to use this medicine according to a regular schedule and you miss a dose, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and use your next dose at the regularly scheduled time.

Storage—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light.
Keep the medicine from freezing.
Do not puncture, break, or burn aerosol containers, even when they are empty.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

After applying this medicine to the skin of a child, watch the child carefully to make sure that he or she does not get any of the medicine into his or her mouth . Topical anesthetics can cause serious side effects, especially in children, if any of the medicine gets into the mouth or is swallowed.

Stop using this medicine and check with your doctor:
If your condition does not improve within 7 days, or if it gets worse .
If the area you are treating becomes infected .
If you notice a skin rash, burning, stinging, swelling, or any other sign of irritation that was not present when you began using this medicine .
If you swallow any of the medicine .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Large swellings that look like hives on the skin or in the mouth or throat

Symptoms of too much medicine being absorbed by the body—very rare

Blurred or double vision; confusion; convulsions (seizures); dizziness or lightheadedness; drowsiness; feeling hot, cold, or numb; headache; increased sweating; ringing or buzzing in the ears; shivering or trembling; slow or irregular heartbeat; troubled breathing; unusual anxiety, excitement, nervousness, or restlessness; unusual paleness; unusual tiredness or weakness

Also, check with your doctor as soon as possible if any of the following side effects occur:

Burning, stinging, or tenderness not present before treatment; skin rash, redness, itching, or hives

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/29/1994

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