Label: SKIN PROTECTANT COCOA BUTTER- petrolatum lotion

  • 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 August 30, 2016

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  • DESCRIPTION

    GLS PERSONAL CARE SOLUTIONS

    Cocoa Butter Petroleum Jelly

    Vitamin E

    Skin Protectant

    With Extra Rich Cocoa Butter

    Tones, softens & smooths dry skin

    4.5 fl. o (133 ml)

  • ACTIVE INGREDIENT

    Active Ingredient

    White Petroleum Purpose

    Petrolatum 30%....................................................................Skin Protectant

  • PURPOSE

    Skin Protectant Lotion

  • INDICATIONS & USAGE

    • Temporarily protect minor cuts, scrapes, & burns
    • Temporarily protects and helps relieve chapped or cracked skin
    • Helps protect from the drying efffects of wind and cold weather
  • WARNINGS

    For external use only.

    When using this product do not get into eyes.

    Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on - deep puncture wounds - animal bites - serious burns

  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison Control Center right away. i

  • INSTRUCTIONS FOR USE

    Apply as needed.

  • DOSAGE & ADMINISTRATION

    Topical skin protectant lotion

    30% Petrolatum

  • INACTIVE INGREDIENT

    water (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, polysorbate 80, laureth - 20, BHT, methylparaben, propylparaben, dimethicone, theobroma cocao (cocoa) seed butter, tocopheryl acetate.

  • PRINCIPAL DISPLAY PANEL

    Cocoa Butter Petroleum Jelly

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT  COCOA BUTTER
    petrolatum lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM39.9 g  in 133 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-254-04133 mL in 1 TUBE; Type 0: Not a Combination Product06/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/30/2016
    Labeler - Great Lakes Wholesale Marketing and Sales, Inc (361925498)
    Registrant - Illinois Industrial Tool, Inc (628032898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Chemical Products co., Ltd530766098manufacture(64092-254)
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