ALLEVESS- menthol, capsaicin patch

ALLEVESS by

Drug Labeling and Warnings

ALLEVESS by is a Otc medication manufactured, distributed, or labeled by API Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

MENTHOL  5.00%
CAPSAICIN  0.05%

PURPOSES:

TOPICAL ANALGESIC
TOPICAL ANALGESIC

USES:

FOR TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF THE MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, BRUISES AND SPRAINS.

WARNINGS:

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

∙ USE ONLY AS DIRECTED

DO NOT USE

DO NOT USE ON, AND AVOID CONTACT WITH, FACE, SCALP, EYES, MOUTH, AND MUCOUS MEMBRANES ∙ DO NOT USE ON WOUNDS OR DAMAGED OR SENSITIVE SKIN ∙ DO NOT USE IN COMBINATION WITH ANY EXTERNAL HEAT SOURCE (HEATING PAD, ETC.) OR FOR 1 HOUR BEFORE OR AFTER BATHING OR SHOWERING ∙ DO NOT USE IN COMBINATION WITH ANY COMPRESSION (BANDAGE, WRAP, BRACE,  STOCKING, SOCK, OR SIMILAR DEVICE OR GARMENT) ∙ DO NOT USE IN COMBINATION WITH ANY OTHER EXTERNAL ANALGESIC PRODUCTS.

STOP USE AND ASK A DOCTOR

STOP USE AND ASK A DOCTOR IF ∙ EXCESSIVE REDNESS, BURNING, SWELLING, IRRITATION, OR DISCOMFORT DEVELOPS IN THE SKIN, EYES, MOUH OR MUCOUS MEMBRANES ∙ CONDITION WORSENS ∙ PAIN PERSISTS FOR MORE THAN 7 DAYS ∙ SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

IF PREGNANT OR BREAST-FEEDING,

ASK A DOCTOR BEFORE USE.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS:

ADULTS AND CHILDREN 16 YEARS AND OVER: APPLY DIRECTLY TO AFFECTED AREA OF PAIN; CHANGE PATCH 1 TO 2 TIMES DAILY, OR AS DIRECTED BY A DOCTOR ∙ CHILDREN UNDER 16 YEARS: ASK A DOCTOR BEFORE USING

HOW TO APPLY:
− CLEAN AND DRY AFFECTED AREA - TEAR OPEN POUCH AND REMOVE ONE PATCH
− REMOVE PROTECTIVE FILM AND APPLY DIRECTLY TO AFFECTED AREA OF PAIN
− RESEAL POUCH CONTAINING UNUSED PATCHES AFTER EACH USE
− WASH HANDS WITH SOAP AND WATER AFTER APPLYING

OTHER INGREDIENTS:

ACRYLIC ACID, ALUMINUM HYDROXIDE, GLYCERIN, METHYL ACRYLATE, CARMELLOSE SODIUM, 2-ETHYLHEXYL ACRYLATE, TARTARIC ACID, POLYACRYLATE, POLYACRYLIC ACID, WATER, SODIUM POLYACRYLATE

QUESTIONS

DISTRIBUTED BY:
A.P.I. SOLUTIONS
DAPHNE, AL 36526
FOR QUESTIONS OR COMMENTS PLEASE CALL 855-878-1489

Principal Display Panel

ALLEVESS PATCH

TOPICAL ANALGESIC PATCH - MENTHOL 5%, CAPSAICIN 0.05%
QTY: 15 PATCHES: (5 PER RESEALABLE POUCH) × 3

LOT:
EXP:
NDC: 46144-162-01

INGREDIENTS AND APPEARANCE

ALLEVESS 
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46144-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Acrylic Acid (UNII: J94PBK7X8S)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Glycerin (UNII: PDC6A3C0OX)
Methyl Acrylate (UNII: WC487PR91H)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
2-Ethylhexyl Acrylate (UNII: HR49R9S6XG)
Tartaric Acid (UNII: W4888I119H)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
Water (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46144-162-01	3 in 1 BOX
1		5 in 1 POUCH
1		100 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2015

Labeler - API Solutions, Inc. (831870824)