Label: WHITE RAIN COCOA BUTTER PETROLEUM JELLY- white petrolatum jelly

  • NDC Code(s): 52862-133-01, 52862-133-03, 52862-133-04, 52862-133-05, view more
    52862-133-06, 52862-133-07
  • Packager: INTERNATIONAL WHOLESALE 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 February 2, 2022

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  • Active Ingredient

    White Petrolatum USP (99%)

  • Purpose

    Skin protectant

  • Uses

    • For the temporary protection of minor cuts, scrapes, burns
    • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

  • Warnings

    For External Use Only

  • DO NOT USE

    Do not use on deep puncture wounds, animal bites, or serious burns. Ask a doctor.

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

    Stop use and ask doctor if condition worsens or does not improve within 7 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 product liberally, as often as necessary.

  • Inactive ingredients

    Theobroma Cacao (Cocoa) Seed Butter, fragrance

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    WHITE RAIN COCOA BUTTER PETROLEUM JELLY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-133
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-133-01170 g in 1 JAR; Type 0: Not a Combination Product01/15/2022
    2NDC:52862-133-06283 g in 1 JAR; Type 0: Not a Combination Product01/15/2022
    3NDC:52862-133-0350 g in 1 JAR; Type 0: Not a Combination Product01/15/2022
    4NDC:52862-133-04113 g in 1 JAR; Type 0: Not a Combination Product01/15/2022
    5NDC:52862-133-05226 g in 1 JAR; Type 0: Not a Combination Product01/15/2022
    6NDC:52862-133-07100 g in 1 JAR; Type 0: Not a Combination Product01/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/08/2022
    Labeler - INTERNATIONAL WHOLESALE INC. (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-133)
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