SANATIVA DRY SKIN RELIEF (PETROLATUM, DIMETHICONE) CREAM [CROSSOVER TELECOM, LLC]

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SANATIVA DRY SKIN RELIEF (PETROLATUM, DIMETHICONE) CREAM [CROSSOVER TELECOM, LLC]
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NDC 70724-844-01
Set ID 589c71cf-32d8-b8ae-e053-2991aa0a0030
Category HUMAN OTC DRUG LABEL
Packager Crossover Telecom, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • DRUG FACTS:

  • Active Ingredient:

    Petrolatum 30.00%

    Dimethicone 3.00%

    Skin protectant

  • Indications:

    • Helps relieve, prevent and temporarily protect chafed, chapped, cracked or wind burned skin.
    • Temporarily protects minor burns, cuts and scrapes.
    • Helps protect skin from the drying effects of wind and cold weather.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Do not use

    • on deep or puncture wounds, on animal bites or on serious burns.

    Keep out of reach of children.

    If swallowed, consult physician.

  • Directions:

    • Apply generously to affected area as need
  • Additional Information:

    Store at room temperature.

  • Inactive Ingredients:

    Allantoin, Aqua (Deionized Water), Butylene Glycol, Carbomer, Ceramide NG, Cetearyl Alcohol, Cetearyl lucoside Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Collagen, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Polysorbate-20, Retinyl Palmitate (Vitamin A), Simmondsia Chinensis (Jojoba) Oil, Sodium Ascorbyl Phosphate (Vitamin C), Sorbitan Olivate, Tocopheryl Acetate (Vitamin E)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SANATIVA DRY SKIN RELIEF 
    petrolatum, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70724-844
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM300 mg  in 1 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70724-844-011 in 1 BOX09/07/2017
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/07/2017
    Labeler - Crossover Telecom, LLC (026911787)
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