Aleveer Patch

Name: Aleveer Patch

Warnings

For external use only

Use only as directed

Avoid contact with eyes and muccous membranes

Do not cover wit hbandage

Do not use on wounds or damaged skin

Consult physician for children under 12

Do not use if you are allergic to menthol

Stop use and ask doctor if conditions worsen, wymptoms persist for more tahn 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs

Keep out of reach of children

Menthol 5.00%

Capsaicin 0.0375%

water, glycerine, sodium polyacrylate, polysorbate80, aloe barbadesis leaf juice, EDTA disodium salt, diazolidinyl urea, methylparaben, iodoproynyl butylcabamate, propylparaben

adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

children under 12 years consult physician before use

how to apply: clean and dry affected area, cut open pouch and remove patch, remove protective film and apply directly to area of pain, apply to affected area not more than 3 times daily, wash hands with soap after applying patch, reseal pouch containing unused patches.

Analgesic/counterirritant

External analgesic

Analgesic/counterirritant

External analgesic

Allever Patch

Aleveer Patch 
menthol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49430-014
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN .0375 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
SODIUM POLYACRYLATE (2500000 MW)  
POLYSORBATE 80  
ALOE VERA LEAF  
EDETATE DISODIUM  
DIAZOLIDINYL UREA  
METHYLPARABEN  
IODOPROPYNYL BUTYLCARBAMATE  
PROPYLPARABEN  
Packaging
# Item Code Package Description
1 NDC:49430-014-15 100 g in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2013
Labeler - Pharmaceutics Corporation (079132026)
Revised: 08/2014   Pharmaceutics Corporation

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad skin irritation.
  • Very bad burning or burning that does not go away.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Burning or stinging feeling. Most of the time, this will go away after a few days.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Aleveer Patch may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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