Label: PAIN (chlorpheniramine maleate, methyl salicylate, scopolia carniolica whole, menthol, peppermint, camphor- synthetic, phellodendron amurense whole patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 12, 2014

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  • ACTIVE INGREDIENT

    EACH PIECE 4.2 CM X 6.5 CM PLASTER CONTAINS:

    MEDICINAL MATERIAL:

    CHLORPHENIRAMINE MALEATE.....13.44 MG

    METHYL SALICYLATE.....26.88 MG

    SCOPOLIA EXTRACT.....2.69 MG

    MENTHOL.....26.88 MG

    PEPPERMINT OIL.....26.88 MG

    CAMPHOR.....13.44 MG

    PHELLODENDRON EXTRACT.....13.44 MG

  • PURPOSE

    PURPOSE

    PAIN RELIEF

  • WARNINGS

    CAUTIONS:

    DO NOT USE THIS PRODUCT IF YOU HAVE A SENSITIVE SKIN.

    DO NOT APPLY TO THE WOUNDED OR DAMAGED SKIN.

    AVOID EYE CONTACT.

    DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR. IF IRRITATION PERSISTS, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENT IN THE PRODUCT, DO NOT USE.

  • INDICATIONS & USAGE

    USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    FOR EXTERNAL USE ONLY.

    ONE PATCH PER DAY. CLEAN SKIN AREA PROR TO USE.

    MORE EFFECTIVE AFTER A HOT APPLICATION (EX. BATH/SHOWER).

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    ADHESIVE PLASTER BASE:

    ZINC OXIDE.....121.70 MG

    OLIVE OIL.....4.90 MG

    RESIN.....133.25 MG

    RUBBER.....266.50 MG

  • PRINCIPAL DISPLAY PANEL

    Med Patch Side 1

    Med patch Side 2

  • INGREDIENTS AND APPEARANCE
    PAIN 
    chlorpheniramine maleate, methyl salicylate, scopolia carniolica whole, menthol, peppermint, camphor (synthetic), phellodendron amurense whole patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69165-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE13.4 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE26.9 mg
    SCOPOLIA CARNIOLICA WHOLE (UNII: XR0I456H79) (SCOPOLIA CARNIOLICA WHOLE - UNII:XR0I456H79) SCOPOLIA CARNIOLICA WHOLE2.7 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL26.9 mg
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL26.9 mg
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)13.4 mg
    PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L) (PHELLODENDRON AMURENSE WHOLE - UNII:3OZN5NGR9L) PHELLODENDRON AMURENSE WHOLE13.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69165-101-5110 in 1 PACKAGE
    1NDC:69165-101-111 in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/12/2014
    Labeler - GEORGE L. RODRIGUEZ M.D., PC (028675061)
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