Label: FAMILY CARE PAIN RELIEF- dl-camphor, l-menthol, methylsalicylate 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 November 26, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients                                                            Purpose

    DL-Camphor 1.2%....................................................Topical Analgesic

    L-Menthol 5.7%........................................................Topical Analgesic

    Methylsalicylate 6.3%................................................Topical Analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backaches
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • if you are allergic to aspirin or salicylates
    • with a heating pad
    • with, or at the same time as, other external analgesic products
  • ASK DOCTOR

    Ask a doctor before use, if you are allergic to any ingredients in this product

  • WHEN USING

    When using this product

    • do not use otherwise than directed
    • avoid contact with the eyes, mucous membranes or rashes
  • STOP USE

    Stop use and ask a doctore if

    • rash, itching or excessive skin irritation develops
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if swallowed, get medical help or contact a Poision Control Center right away

  • INDICATIONS & USAGE

    Directions

    Aduts and children 12 years of age and over:

    • clean and dry affected area
    • remove patch from film
    • apply to affected area no more than 3 to 4 times daily for 7 days
    • remove patch from skin after at most 8 hours of application

    Children under 12 years of age:

    • consult a doctor
  • STORAGE AND HANDLING

    Other Information

    • avoid storing product in direct sunlight
    • protect from excessive moisture
  • INACTIVE INGREDIENT

    Inactive Ingredients

    BHT, calcium carbonate, C4-6 oletin / styrene copolymer, glycerol abietate, isopropyl myristate, polybutene, polyisobutene, propylene carbonate, rubber latex, sorbitian stearate, ys resin, zinc oxide

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE PAIN RELIEF 
    dl-camphor, l-menthol, methylsalicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-385
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL5.7 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    STYRENE (UNII: 44LJ2U959V)  
    GLATIRAMER ACETATE (UNII: 5M691HL4BO)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-385-2020 in 1 BOX
    12.0 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/26/2013
    Labeler - United Exchange Corp. (840130579)
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