WESTERN FAMILY PAIN RELIEVING (CAMPHOR) CREAM [WESTERN FAMILY FOOD, INC.]

WESTERN FAMILY PAIN RELIEVING (CAMPHOR) CREAM [WESTERN FAMILY FOOD, INC.]
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NDC 55312-054-04
Set ID d3913547-d9aa-4202-bb5d-c1ca1424247a
Category HUMAN OTC DRUG LABEL
Packager Western Family Food, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Enter section text here

  • PURPOSE

    Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings for external use only.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion.

    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • INDICATIONS & USAGE

    Directions

    • use only as directed
    • adults and children 12 years of age and older: apply area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Store between 20° and 25° C (68° and 77° F)
  • INACTIVE INGREDIENT

    Inactive ingredients DEA-cetyl phosphate, glycerin, isopropyl myristate, methylparaben, polysorbate 60, propylparaben, purified lanolin, purified water, sorbitan stearate, stearyl alcohol, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Western Family Foods, Inc.

    P.O. Box 4057

    Portland, OR 97208 U.S.A.

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY PAIN RELIEVING  
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.04 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.3 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-054-041 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - Western Family Food, Inc. (192166072)

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