Allevess patch

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

Otc - questions section

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

Ingredients and appearance - Product information

Allevess patch- Menthol, capsaicin

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 5 gin 100 g
Capsaicin ( UNII: S07O44R1ZM)( Capsaicin - UNII: S07O44R1ZM ) 0.05 gin 100 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - API Solutions, Inc.( 831870824)

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