Label: NOURISHING CREAM- mineral oil, glycerin cream

  • 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 February 22, 2017

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

  • USES

    . helps to prevent dehydration of the skin

    . heps maintain the hydrolipidic layer of the skin.

    USES

    .helps to precent dehydration of the skin

    .helps maintain the hydrolipidic layer of the skin

  • ACTIVE INGREDIENTS

    ACTIVE INGREDIENTS PURPOSE

    Mineral Oil 20%.................. Skin protectant

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

  • 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

    Children under 6 months: ask a doctor

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

  • DIRECTIONS

    . apply every day gently onto clean face and neck.

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

    DIRECTIONS

    . apply every day gently onto clean face and neck.

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

  • OTHER INFORMATION

    . keep the product in a cool and dry place

  • INACTIVE INGREDIENTS

    Water, Macadamia ternifolia seed oil, Egg yolk extract, Glyceryl stearate, Phenoxyethanol, Lecithin , Cetyl phosphate, Triethanolamine, Carbomer, Fragrance, Sodium hyaluronate, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Perfluorodecalin, Jojoba seed oil, BHT, Ceramide NP, Sucrose Palmitate, Tocopherol, Xanthan gum, Sodium benzoate, Potassium sorbate, Ascorbyl palmitate

    Bottle

  • QUESTIONS OR COMMENTS?

    + 34 961 501 999

    M-F 9:00 am to 5:00 pm

  • PURIFYING OXYGENATING NOURISHING CREAM

    bOX

    Purifying Nourishing Cream

    Purifying Nourishing Cream

  • Purifying Nourishing Cream

    Box

  • INGREDIENTS AND APPEARANCE
    NOURISHING CREAM 
    mineral oil, glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-084
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL20 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MACADAMIA OIL (UNII: 515610SU8C) 5.99 mg  in 1 mL
    EGG YOLK (UNII: 4IPS17B70T) 2 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.001 mg  in 1 mL
    ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0005 mg  in 1 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.01 mg  in 1 mL
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 59.7 mg  in 1 mL
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.625 mg  in 1 mL
    CETYL PHOSPHATE (UNII: VT07D6X67O) 0.625 mg  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.6 mg  in 1 mL
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.4 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
    PERFLUNAFENE (UNII: 54A06VV62N) 0.035 mg  in 1 mL
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) 0.015 mg  in 1 mL
    CERAMIDE NS DILAURATE (UNII: 1SL625KAAV) 0.006 mg  in 1 mL
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5) 0.006 mg  in 1 mL
    TOCOPHEROL (UNII: R0ZB2556P8) 0.003 mg  in 1 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.001 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.001 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-084-021 in 1 CARTON02/22/2017
    1NDC:20151-084-011 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/02/2015
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-084)