Label: ONE GEL SPORT PAIN RELIEVING (camphor- synthetic and menthol gel

  • 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 August 22, 2014

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  • SPL UNCLASSIFIED SECTION

    Phyto Creativ Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Camphor 3%Pain Reliever
    Menthol 2.2%Pain Reliever
  • Uses

    For the temporary relief of minor aches and pains of muscles and joints

  • Warnings

    For external use only

    Do not use on wounds, damaged skin or irritated areas a heating pad on treated area

    When using this product use only as directed avoid contact with eyes and mucous membranes do not bandage tightly

    Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days conditions clear up and occur again within a few days.

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

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

  • Directions

    Adults and Children 7 years of age and older: apply to the affected area up to 3 times daily, as needed.

  • Inactive Ingredients

    Alcohol, carbomer, equisetum arvense extract, FD&C Blue No. 1, limonene, linalool, malaleuca leucadendron cajaput oil, potassium sorbate, PPG-1-PEG-9 lauryl glycol esther, rosmarinus officinals malaleuca, sodium benzoate, sodium hydroxide, thymus vulgaris, water.

  • SPL UNCLASSIFIED SECTION

    Distributed by One Gel USA Inc.
    Lighthouse Point, FL 33064

  • PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label

    one gel Sport

    TWIST CAP TO OPEN

    Laboratoires
    Phyto
    Creativ

    USA

    Paraben free
    Phenoxyethanol free
    Essential oils

    ①™
    one gel
    Sport

    Pain Relieving Gel

    NET WT : 3.38 oz. (100 ml)

    Principal Display Panel - 100 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ONE GEL SPORT   PAIN RELIEVING
    camphor (synthetic) and menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69023-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)30 mg  in 1 mL
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol22 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    equisetum arvense branch (UNII: 1L0VKZ185E)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    linalool, (+/-)- (UNII: D81QY6I88E)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69023-100-30100 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34807/04/2014
    Labeler - Phyto Creativ (263842260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phyto Creativ263842260MANUFACTURE(69023-100)
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