Label: CREATIONS GARDEN PAIN RELIEF ROLL ON- camphor, menthol, and methyl salicylate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 10, 2010

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  • Active Ingredients

    Camphor 4%
    Menthol 10%
    Methyl Salicylate 30%


  • Purpose


    .……..…….............….. Topical Analgesic

    ...……......……….....… Topical Analgesic

    .......….......… Topical Analgesic


  • Uses

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

    • arthritis
    • strains
    • bruises
    • sprains
    • backache
  • 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

  • Keep out of reach of children

    In case of accidental ingestion, seek medical assistance 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


  • INACTIVE INGREDIENT

    Water, Hydroxyethyl Cellulose, Edetate Disodium, Glyceryl Stearate Se,  Sorbitan Stearate, Stearic Acid,  Polysorbate 80, Potassium Hydroxide,  Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol

  • Questions?

    Call 1-859-422-7048

  • PRINCIPAL DISPLAY PANEL

    Placeholder Text

    CG Pain Relief Rollon

  • INGREDIENTS AND APPEARANCE
    CREATIONS GARDEN  PAIN RELIEF ROLL ON
    camphor, menthol, and methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 2.96 mL  in 74 mL
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7.4 mL  in 74 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate22.2 mL  in 74 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-024-2674 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/10/2010
    Labeler - Creations Garden Natural Products, Inc. (961956229)
    Registrant - Creations Garden Natural Products, Inc. (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products, Inc. 961956229manufacture
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