Label: PURIFYING OXYGENATING MOISTURIZING CREAM- mineral oil, glycerin cream

  • 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 February 22, 2017

If you are a consumer or patient please visit this version.

  • DIRECTIONS

    . apply every day gently onto clean face and neck

    . can be used in the morning and/or night.

  • ACTIVE INGREDIENTS PURPOSE

    Mineral Oil 20%..................Skin Protectant

    Glycerin 6.5%..................... Skin Protectant

    Bottle

  • WARNINGS

    Children under 6 months: ask a doctor

    WARNINGS

    Keep out of reach of children

  • USES

    . helps to prevent dehydration of the skin

    . helps maintain the hydrolipidic layer of the skin

    DIRECTIONS

    . apply every day gently onto clean face and neck

    . can be used in the morning and/or night.

  • WARNINGS

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    When using this product do not get into eyes.

    Children under 6 months: ask a doctor

  • OTHER INFORMATION

    keep the product in a cool and dry place.

  • INACTIVE INGREDIENTS

    water, peg-40 castor oil, phenoxyethanol, sodium polyacrylate, betaine, cyclopentasiloxane, trideceth-6, ribose, fragrance, ethylhexylglycerin, tetrasodium glutamate diacetate, peg/ppg- 18/18 dimethicone, perfluorodecalin, simmondsia chinensis (jojoba) seed oil, ceramide np, sucrose palmitate, xanthan gum, sodium benzoate, potassium sorbate.

  • QUESTIONS OR COMMENTS?

    + 34 961 501 999 M-F 9:00 am to 5:00 pm

  • Purifying Oxygenating Moisturizing Cream

    Box

  • INGREDIENTS AND APPEARANCE
    PURIFYING OXYGENATING MOISTURIZING CREAM 
    mineral oil, glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.5 mg  in 1 mL
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL17 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EGG YOLK (UNII: 4IPS17B70T) 2 mg  in 1 mL
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.62 mg  in 1 mL
    CETYL PHOSPHATE (UNII: VT07D6X67O) 0.625 mg  in 1 mL
    MACADAMIA OIL (UNII: 515610SU8C) 4.99 mg  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.6 mg  in 1 mL
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.45 mg  in 1 mL
    RIBOSE, D- (UNII: 681HV46001) 0.2 mg  in 1 mL
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) 0.1 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    TOCOPHEROL (UNII: R0ZB2556P8) 0.002 mg  in 1 mL
    ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0005 mg  in 1 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.011 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 63.59 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-083-021 in 1 CARTON02/23/2017
    1NDC:20151-083-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/23/2017
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-083)