ALEVEER PATCH- menthol and capsaicin patch
Pharmaceutics Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

box image

ALEVEER PATCH
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49430-014
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (MENTHOL)	MENTHOL	5 g in 100 g
CAPSAICIN (CAPSAICIN)	CAPSAICIN	0.0375 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER
GLYCERIN
SODIUM POLYACRYLATE (2500000 MW)
POLYSORBATE 80
ALOE VERA LEAF
EDETATE DISODIUM
DIAZOLIDINYL UREA
METHYLPARABEN
IODOPROPYNYL BUTYLCARBAMATE
PROPYLPARABEN

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49430-014-15	100 g in 1 PATCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2013	01/06/2015

Labeler - Pharmaceutics Corporation (079132026)

Revised: 1/2015

Document Id: 4e10cc13-ee23-4d1d-a985-7b2b4c72a307

Set id: 3eb3b2d8-3714-427e-8f69-3365940df750

Version: 7

Effective Time: 20150106

Pharmaceutics Corporation