Label: FAMILY CARE ULTRA STRENGTH PAIN RELIEF- camphor, menthol ointment

  • 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 February 14, 2012

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  • ACTIVE INGREDIENT

    Active ingredients                                                                      Purpose

    Camphor 11% ...........................................................................Topical analgesic

    Menthol 11% ............................................................................Topical analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • Avoid contact with eyes and mucous membranes
    • Do not apply to open wounds or damaged skin
    • Do not bandage or use heating pad
  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than seven days
    • Pain clears up and then recurs few days later
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Directions

    • Rub well on the affected area.  Repeat 3 to 4 times daily.
    • For children 2-12 years, consult a doctor before use.
  • STORAGE AND HANDLING

    Other information

    This product may cause allergic reaction in some individuals.  Test on small area before use.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Cajuput Oil, Clove Oil, Dementholized Mint Oil and Paraffin Petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ULTRA STRENGTH PAIN RELIEF 
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL110 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-008-321 in 1 CARTON
    18 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/14/2012
    Labeler - UNITED EXCHANGE CORP. (840130579)
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