Label: PAIN RELIEF RUB IAMPUR- camphor, menthol, methyl salicylate cream

  • 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 November 15, 2017

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  • ACTIVE INGREDIENT

    Camphor 4%, Menthol 4%, Methyl Salicylate 11%

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, back ache, strains, bruises, and sprains.

  • WARNINGS

    Warnings

    For external use only. Use only as directed.  Consult your doctor before use if you have allergies to aspirin or salicylate.  Avoid contact with eyes and mucous membranes.  If contact occurs, flush with water for 15 minutes.  Do not apply to wounds or damaged skin.  If pain persists for more than 7 days or becomes worse consult a physician.  Children under 12 years of age should consult a physician before use. 

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Arnica Montana, Carbomer, Cetearyl Alcohol, Ceteth-10 Phosphate, Dicetyl Phosphate, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Oryza sativa (Rice) Bran Oil, Phenoxyethanol, Purified Water, Sodium Hydroxide

  • PURPOSE

    Purpose

    Topical Analgesic.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF RUB  IAMPUR
    camphor, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43493-0001-1198 g in 1 TUBE; Type 0: Not a Combination Product10/30/2017
    2NDC:43493-0001-256 g in 1 TUBE; Type 0: Not a Combination Product10/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/30/2017
    Labeler - Avaria Health & Beauty Corp (248926979)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(43493-0001)
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