Label: CAREALL CREAMY COCOA BUTTER PETROLEUM JELLY- petrolatum cream

  • NDC Code(s): 51824-083-03
  • Packager: New World Imports, Inc
  • 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 December 31, 2020

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

  • Active Ingredient

    White Petrolatum USP

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor: cuts, scrapes and burns
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only. Do not use on deep puncture wounds, animal bites and serious burns.

    When using this product, do not get into eyes.

    Stop use and ask a doctor if:

    •condition worsens

    •symptoms last more than 7 days

    •clear up and occur again within a few days

  • Keep out of reach of Children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed.

  • Inactive Ingredients

    water (aqua), glycerin, glyceryl monostearate, PEG—100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    51824-083-03 Cocoa PJ

  • INGREDIENTS AND APPEARANCE
    CAREALL CREAMY COCOA BUTTER PETROLEUM JELLY 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-083-0385 g in 1 TUBE; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2021
    Labeler - New World Imports, Inc (075372276)