ALLEVESS- menthol, capsaicin patch 
API Solutions, Inc.

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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API Solutions - 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

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

Principal Display Panel

Image of Box Label

ALLEVESS PATCH

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

LOT:
EXP:
NDC: 46144-162-01

ALLEVESS 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46144-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46144-162-013 in 1 BOX
15 in 1 POUCH
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2015
Labeler - API Solutions, Inc. (831870824)

Revised: 12/2015
Document Id: ea916cea-85dd-4b38-8475-a33ab762b9b5
Set id: 1982db88-d00d-4ba7-ae87-190799556709
Version: 1
Effective Time: 20151202
 
API Solutions, Inc.