Label: ZEROMA7- peppermint oil, camphor oil gel

  • Category: HUMAN OTC DRUG LABEL

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 October 8, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Uses

    Uses Aroma therapy blend essential oil for temporary relieves minor aches, pains of muscles and joints associated with:

    Arthritis Simple backache Strains Bruises Sprains

  • Warnings

    For external use only

    Do not use on wounds or damaged skin with a heating pad

    if you are allergic to any ingredients of this product

    with other external analgesic products

    When using this product

    Use only as directed

    avoid contact with eyes, mucous membranes or rashes

    do not bandage tightly

    Stop use and ask a doctor if

    rash, itching, or excessive skin irritation develops

    conditions worsen

    symptoms persist for more than 7 days

    symptoms clear up and occur again within a few days

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    If pregnant or breast-feeding, ask a health professional before use

  • Active Ingredients

    Peppermint Oil 8% ------------------------------------ Topical Analgesic

    Camphor Oil 8% --------------------------------------- Topical Analgesic

  • Purpose

    Topical Analgesic

  • Directions

    Adults and children 12 years of age and over:

    Clean and dry affected area

    Remove patch from film

    Apply to affected area no more than 3 to 4 times daily for 7 days

    Remove patch from skin after at most 8 hours’ application

    Children undress 12 years of age: consult a doctor

  • Inactive Ingredients

    Gaultheria Procumbens (Wintergreen) Oil, Rosmarinus Officinalis (Rosemary) Oil, Citrus Paradisi (Grapefruit) Oil, Heterotheca Inuloides (Arnica Herbal) Oil, Aloe Vera Leaf Extract, Witch Hazel, Olive Oil, Carbomer, Water, Stearic Acid, Propylene Glycol, Isopropyl Palmitate, Cetyl Alcohol, Glycerol Stearate, Lanolin, Polymethoxy Bicyclic Oxazolidine, Mineral Oil & Lanolin Alcohol, Allantoin, Tocopherol Acetate, Aloe Vera Gel, Methyl Paraben, Urea, Potassium Hydroxide, Chloroxylenol, Propyl Paraben, Sodium Hydroxide.

  • Zeroma7

    ZEROMA Label Review by JK 100118

  • INGREDIENTS AND APPEARANCE
    ZEROMA7 
    peppermint oil, camphor oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72589-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6.8 g  in 85 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL6.8 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72589-100-0185 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/08/2018
    Labeler - Ingenue Care Inc (111556736)
    Registrant - Ingenue Care Inc (111556736)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ingenue Care Inc111556736manufacture(72589-100)