Label: AT ONE WITH NATURE- menthol 1% gel, dentifrice

  • 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 3, 2014

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  • ACTIVE INGREDIENT

    Menthol 1.00%

  • PURPOSE

    Topical Analgesic

  • USE

    temporary relief of itching associated with scalp irritation.

  • WARNINGS

    • for external use only

    When using this product

    • avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days.

    • excessive skin irritation

    Keep out of reach of children.

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

  • Directions

    • Adult & children 2 year of age & older. Part hair into section & apply a dime size amount sparingly.
    • Massage into scalp to invigorate and insure absorption.
    • Apply to affected area not more then 3 to 4 times daily. Use daily for maximum results or flaking & itching has stopped.
    • Children under 2 years of age ask a doctor
  • INACTIVE INGREDIENTS

    Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Salicylic Acid, Polyethylene, Paraffin, Propylene Glycol, Water, Calendula Officinalis (Pot Marigold ) Flower Extract, Anthemis Nobilis Chamomile Flower Extract , Tilia Cordata (Linden)Flower Extract, Centaurea Cyanus (Cornflower) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Extract (St. John's Wort) Extract, Fragrance, Olea Europaea (Olive) Fruit Oil, Sulfur, Sesame (Sesamum Indicum) Oil, Tocopheryl Acetate, BHT, Propylparaben, Green 6, Yellow 11

  • PRINCIPAL DISPLAY PANEL

    biocare5oz

    biocare5oz

  • INGREDIENTS AND APPEARANCE
    AT ONE WITH NATURE 
    menthol 1% gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54602-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SULFUR (UNII: 70FD1KFU70)  
    SESAME OIL (UNII: QX10HYY4QV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54602-011-05154 g in 1 CANISTER09/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/18/2014
    Labeler - BIOCARE LABS INC. (798953493)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(54602-011)
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