PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]

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  • PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]

PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]
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NDC 36800-042-04
Set ID 9e4c7e73-910c-4a75-8570-2d650006ce93
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients


    Camphor 4%

    Menthol 10%

    Methyl Salicylate 30%


  • Uses

    temporarily relieves the minor aches and pains of muscle and joints associated with: simple backache, arthritis, bruises, sprains

  • WARNINGS

    For external use only.

    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 a doctor before use if you have

    redness over the affected area

    When using this product

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

    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 to avoid accidental ingestion.

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

  • Directions

    • Use only as directed
    • adults and children 12 years of age and older:
                 apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:  ask a doctor
  • Other information

    • Store at 20° to 25°C (68°to 77°F)

  • Inactive Ingredients

    carbomer940, cetyl alcohol, glyceryl monostearate, isopropyl myristate, polysorbate60, purified water, stearic acid, trolamine

  • PRINCIPAL DISPLAY PANEL

    Pain Relief Rubimage of carton label

  • PURPOSE

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF RUB 
    camphor,menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-30 g  in 100 g
    Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-042-041 in 1 BOX
    1114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2013
    Labeler - Topco Associates LLC (006935977)
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