Label: FAMILY CARE THERA FLEX PAIN- capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide 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 September 30, 2012

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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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