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RELIEVER

Medically reviewed on December 4, 2017

Dosage form: patch
Ingredients: MENTHOL 5g in 100g, CAPSAICIN 0.05g in 100g
Labeler: API Solutions, Inc.
NDC Code: 46144-163

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.

API Solutions - Reliever Patch

ACTIVE INGREDIENTS:

MENTHOL 5.00%
CAPSAICIN 0.05%

PURPOSES

TOPICAL ANALGESIC
TOPICAL ANALGESIC

USES:

FOR TEMPORARY RELIEF OF 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 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, 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

RELIEVER PATCH

TOPICAL ANALGESIC - MENTHOL 5%, CAPSAICIN 0.05%
Qty: 15 Patches: (5 per Resealable Pouch) × 3

LOT:
EXP:
NDC: 46144-163-01

RELIEVER 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46144-163
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
GLYCERIN 
METHYL ACRYLATE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
2-ETHYLHEXYL ACRYLATE 
TARTARIC ACID 
POLYACRYLIC ACID (8000 MW) 
WATER 
SODIUM POLYACRYLATE (2500000 MW) 
Packaging
#Item CodePackage Description
1NDC:46144-163-013 POUCH in 1 BOX
15 PATCH in 1 POUCH
1100 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2015
Labeler - API Solutions, Inc. (831870824)

 
API Solutions, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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