Label: HYDRA LIFTING FIRMING NOURISHING CREAM- 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 25, 2017

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

  • ACTIVE INGREDIENTS PURPOSE

    Glycerin 13%.................... Skin Protectant

    Bottle

  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    Whhen using this product do not get into eyes.

    Children under 6 months: as a doctor.

    WARNINGS

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

    Warnings

    Keep out of reach of children

  • Questions or comments?

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

  • Other Information

    . keep the product in a cool and dry place

  • Directions

    . apply every day gently onto clean face and neck

    . can be used in the morning and/or night

    . apply every day gently onto clean dace and neck

    . can be used in the morning and/or night

  • Uses

    . helps to prevent dehydration of the skin.

    . helps maintain the hydrolipidic layer of the skin

    . helps to combat the signs of ageing

  • Inactive Ingredients

    Potassium olivoyl hydrolyzed oat protein, Cetearyl alcohol, Glyceryl stearate, Tocopheryl acetate, Caprylic/capric triglyceride, Phenoxyethanol, Fragrance, Glyceryl oleate, Lysolecithin, Sclerotium gum, Ethylhexylglycerin, Tetrasodium glutamate diacetate,, Xanthan gum, Pullulan, Citric acid , Alaria esculenta extract, Potassium sorbate, Sodium benzoate, Benzyl alcohol, Undaria pinnatifida extract

  • Uses

    . helps to prevent dehydration of the skin

    . helps maintain the hydrolipidic layer of the skin

    . helps to nourish the skin

  • Package Label

    Box

  • INGREDIENTS AND APPEARANCE
    HYDRA LIFTING FIRMING NOURISHING CREAM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 1.05 mg  in 1 mL
    RICE BRAN OIL (UNII: LZO6K1506A) 17 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.1 mg  in 1 mL
    BETASIZOFIRAN (UNII: 2X51AD1X3T) 0.175 mg  in 1 mL
    ALARIA ESCULENTA (UNII: EJ9JK8J58D) 0.05 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 62.376 mg  in 1 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.075 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    GLYCERYL OLEATE (UNII: 4PC054V79P) 0.175 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.035 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.035 mg  in 1 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.05 mg  in 1 mL
    PULLULAN (UNII: 8ZQ0AYU1TT) 0.075 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.035 mg  in 1 mL
    OCTANOIC ACID 1-C-13 (UNII: E775ICF82G) 0.95 mg  in 1 mL
    POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62) 1.05 mg  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1 mg  in 1 mL
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) 0.2 mg  in 1 mL
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) 0.175 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-090-021 in 1 BOTTLE, DISPENSING02/25/2017
    1NDC:20151-090-0150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/25/2017
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-090)