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FAMILY CARE THERA FLEX PAIN (UNITED EXCHANGE CORP)

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PATCH 1 PATCH in 1 POUCH (65923-100-10) Label Information

Complete FAMILY CARE THERA FLEX PAIN Information

  • ACTIVE INGREDIENT

    Active ingredients (in each patch)                                                                                           Purpose

    Capsaicin 0.0056%...............................................................................................................Topical analgesic

    DL-Camphor 1.48%...............................................................................................................Topical analgesic

    L-Menthol 3.95%...................................................................................................................Topical analgesic

    Methyl salicylate 3.95%.........................................................................................................Topical analgesic

    Peppermint oil 1.95%.............................................................................................................Skin protectant

    Zinc oxide 18.77%.................................................................................................................Skin protectant


  • PURPOSE

    Uses

    Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

    • strains
    • sprains
    • simple backache
    • arthritis
    • bruises

  • WARNINGS

    Warnings   For external use only


  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin

  • STOP USE

    Stop use and ask a doctor if

    • conditions worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately.


  • INDICATIONS & USAGE

    Directions

    adults and children over 12 years:

    • carefully remove backing from patch
    • apply sticky side of patch to affected area
    • repeat as necessary, but no more than 4 times daily
    children 12 years or younger:

    • ask a doctor

  • STORAGE AND HANDLING

    Other information

    • some individuals may not experience pain relief until several hours after applying the patch
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
    • store at 20o-25oC (68o-77oF)

  • INACTIVE INGREDIENT

    Inactive ingredients

    butylated hydroxytoluene, calcium carbonate, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, terpene resin


  • DOSAGE & ADMINISTRATION

    Distributed by:

    UNITED EXCHANGE CORP.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea


  • INGREDIENTS AND APPEARANCE
    FAMILY CARE THERA FLEX PAIN  
    capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0056 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1.48 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.95 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 3.95 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 1.95 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.77 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-100-10 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/30/2012
    Labeler - UNITED EXCHANGE CORP (840130579)