Label: MENTHOL- cellulitica oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • 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 February 17, 2016

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  • active ingredient

    menthol(1%) analgesic, External
    Uses

  • Uses

    Helps relieve the condition of cellulitis infection.

  • Dosage Suggestion

    Adults 10ml maximum per day, Children 5ml maximum per day

  • Directions

    Apply on skin and gentle massage around infected area.

  • Inactive Ingredient

    Thyme Oil, Peppermint Oil, Lemon Oil, Lavender Oil, Geranium Oil (Algerian Type), Olive Oil, Almond Oil, Sunflower Oil, Evening Primrose Oil, Calendula Officinalis Seed Oil.

  • Warning

    • For external use only.
    • Stop use and ask doctor if rash occurs.
    • Keep out reach of children.

    Warning

    Keep out reach of children.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • package label

    fact

    all

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    cellulitica oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1011
    Route of AdministrationTOPICALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) 4.5 mL  in 50 mL
    ALMOND OIL (UNII: 66YXD4DKO9) 12 mL  in 50 mL
    PHENOL (UNII: 339NCG44TV) 3 mg  in 50 mL
    OLIVE OIL (UNII: 6UYK2W1W1E) 21 mL  in 50 mL
    LEMON OIL (UNII: I9GRO824LL) 1 mL  in 50 mL
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) 1 mL  in 50 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) 1 mL  in 50 mL
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) 6 mL  in 50 mL
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1011-550 mL in 1 BOTTLE, DROPPER; Type 6: Drug/Biologic Combination02/29/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/29/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - PHYTOPIA CO., LTD. (656940504)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHYTOPIA CO., LTD.656940504manufacture(70470-1011) , label(70470-1011)