Label: SELFF-AID COCOA BUTTER PETROLEUM JELLY- white petrolatum jelly

  • NDC Code(s): 80936-003-01
  • Packager: Docent Pharma Services, LLC
  • 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 23, 2021

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  • Active Ingredient

    White Petrolatum USP (99.9%)

  • Purpose

    Skin protectant

  • Uses

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

    For external use only.

  • WHEN USING

    When using this product do not get into eyes

  • ASK DOCTOR

    See a doctor if condition lasts more than 7 days

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed

  • Inactive ingredients

    fragrance, theobroma cacao (cocoa) seed butter

  • Questions?

    Call 1-229-310-0111

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Docent Pharma Services, LLC
    1533 Armscroft Lane, Apex, NC, 27502
    Made in India
    www.docentpharma.com

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 80936-003-01

    Selff-Aid Cocoa Butter Petroleum Jelly

    Skin Protectant

    NET WT 4 OZ (113 g)

    label

  • INGREDIENTS AND APPEARANCE
    SELFF-AID COCOA BUTTER PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80936-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80936-003-01113 g in 1 JAR; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2022
    Labeler - Docent Pharma Services, LLC (117713970)
    Registrant - Docent Pharma Services, LLC (117713970)
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