Label: NOURISHING CREAM- mineral oil, glycerin cream

  • NDC Code(s): 20151-084-01, 20151-084-02
  • Packager: Casmara Cosmetics, SA
  • 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.

  • 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

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  • ACTIVE INGREDIENTS

    ACTIVE INGREDIENTS PURPOSE

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

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

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  • 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.

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  • 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.

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  • OTHER INFORMATION

    . keep the product in a cool and dry place

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  • 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

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  • QUESTIONS OR COMMENTS?

    + 34 961 501 999

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

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  • PURIFYING OXYGENATING NOURISHING CREAM

    bOX

    Purifying Nourishing Cream

    Purifying Nourishing Cream

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  • Purifying Nourishing Cream
  • INGREDIENTS AND APPEARANCE
    NOURISHING CREAM 
    mineral oil, glycerin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-084
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 20 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:20151-084-02 1 in 1 CARTON 02/22/2017
    1 NDC:20151-084-01 1 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/02/2015
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    Name Address ID/FEI Business Operations
    Casmara Cosmetics, SA 464973544 manufacture(20151-084)
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