Label: 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 2, 2011

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  • ACTIVE INGREDIENT


    Active Ingredient                                     Purpose

    Petrolatum 5%                                      Skin Protectant


  • PURPOSE


    Skin Protectant
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Use daily, do not use around eye area

  • WARNINGS

    For external use only, Do not use around the eye area.Stop use and ask a doctor if redness or imitation develop and persist for more than 7 days

  • DOSAGE & ADMINISTRATION

    apply as needed

  • INACTIVE INGREDIENT

    water, mineral oil, cetyl alcohol, glyceryl stearate, glycerin, dimethicone, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, ammonium polyacrylate, steareth-30, tocopheryl acetate, cocoa butter, shea butter extract, fragrance, blue 1, red 33, yellow 5, yellow 6  

  • PRINCIPAL DISPLAY PANEL


    image of bottle label

  • INGREDIENTS AND APPEARANCE
    COCOA BUTTER 
    petrolatum lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum 5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    mineral oil (UNII: T5L8T28FGP)  
    cetyl alcohol (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    glycerin (UNII: PDC6A3C0OX)  
    dimethicone (UNII: 92RU3N3Y1O)  
    propylene glycol (UNII: 6DC9Q167V3)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    steareth-30 (UNII: 5776GCL1DG)  
    cocoa butter (UNII: 512OYT1CRR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1108-1396.9 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/02/2011
    Labeler - GREENBRIER INTERNATIONAL (610322518)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture
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