Label: SHEA BUTTER PETROLEUM JELLY- petrolatum jelly jelly

  • NDC Code(s): 30400-501-01, 30400-501-02, 30400-501-03, 30400-501-04, view more
    30400-501-05, 30400-501-06, 30400-501-07, 30400-501-08
  • Packager: Jell Pharmaceuticals Pvt. Ltd.
  • 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 October 4, 2021

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  • Active Ingredient

    White Petrolatum USP (99.6%)

  • 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 this product

    do not get into eyes

  • Stop use and ask a doctor if

    condition worsens, symptoms last longer than 7 days or clear up and occur again within a few days

  • Do not use on

    deep or 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.

  • Directions

    apply as needed

  • Inactive ingredients

    butyrospermum parkii (shea butter), fragrance

  • Questions or comments?

    1-800-925-4733

  • Label

    Shea Butter Petroleum Jelly

  • INGREDIENTS AND APPEARANCE
    SHEA BUTTER PETROLEUM JELLY 
    petrolatum jelly jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y) 0.1 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-501-01368 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    2NDC:30400-501-0249 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    3NDC:30400-501-03100 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    4NDC:30400-501-04113 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    5NDC:30400-501-05170 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    6NDC:30400-501-06425 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    7NDC:30400-501-07226 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    8NDC:30400-501-08283 g in 1 JAR; Type 0: Not a Combination Product10/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/10/2021
    Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(30400-501)
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