FAMILY CARE THERA FLEX PAIN (CAPSAICIN, CAMPHOR, MENTHOL, METHYL SALICYLATE, PEPPERMINT OIL, ZINC OXIDE) PATCH [UNITED EXCHANGE CORP]

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  • FAMILY CARE THERA FLEX PAIN (CAPSAICIN, CAMPHOR, MENTHOL, METHYL SALICYLATE, PEPPERMINT OIL, ZINC OXIDE) PATCH [UNITED EXCHANGE CORP]

FAMILY CARE THERA FLEX PAIN (CAPSAICIN, CAMPHOR, MENTHOL, METHYL SALICYLATE, PEPPERMINT OIL, ZINC OXIDE) PATCH [UNITED EXCHANGE CORP]
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NDC 65923-100-10
Set ID 85171b3e-01f6-49d0-b313-1b6e939fcadd
Category HUMAN OTC DRUG LABEL
Packager UNITED EXCHANGE CORP
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE THERA FLEX PAIN  
    capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0056 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.48 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.95 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3.95 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL1.95 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.77 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-100-101 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/30/2012
    Labeler - UNITED EXCHANGE CORP (840130579)
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