Label: CARING MILLS PETROLEUM JELLY- white petrolatum jelly

  • 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 May 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    White Petroleum USP 100%

    Active ingredientsPurpose
    White Petrolatum 100%Skin Protectant
  • Uses

    • helps protect chapped or cracked skin and lips
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • if the condition lasts more than 7 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 (1-800-222-1222) right away.

  • Directions

    Apply as needed

  • Inactive ingredient

    Water

  • Caring Mills Petroleum Jelly

    label

  • INGREDIENTS AND APPEARANCE
    CARING MILLS PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-207-01212 g in 1 JAR; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2023
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(71101-207)
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