FAMILY CARE PAIN RELIEF (DL-CAMPHOR, L-MENTHOL, METHYLSALICYLATE) PATCH [UNITED EXCHANGE CORP.]

FAMILY CARE PAIN RELIEF (DL-CAMPHOR, L-MENTHOL, METHYLSALICYLATE) PATCH [UNITED EXCHANGE CORP.]
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NDC 65923-385-20
Set ID cead2f1d-3b21-4a06-a83e-ac0fdff4222e
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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