Label: ALLEVESS- menthol, capsaicin patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 2, 2015

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  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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)
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