Label: HEALTH SMART COCOA BUTTER PETROLEUM- white petroleum jelly

  • NDC Code(s): 52862-014-01, 52862-014-14, 52862-014-19, 52862-014-20, view more
    52862-014-21, 52862-014-22, 52862-014-23, 52862-014-24, 52862-014-25, 52862-014-26
  • Packager: Home Smart Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petroleum (99.9%)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    • Temporarily protects minor cuts, scrapes or burns.

    • Temporarily protects and helps relieve chapped or cracked skin and lips.

    • Helps protect from the drying effects of wind and cold weather.

  • WARNINGS

    Warning:

    For External Use Only.

  • DO NOT USE

    Do not use on:

    • deep or puncture wounds
    • lacerations or infections
    • serious burns
    • animal bites
  • STOP USE

    Stop use and ask doctor

    • if condition does not improve or lasts more than 7 days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed get medical help or contact Poison Control Center right away.
    • if redness or swelling developes, consult a physician promptly.
  • DOSAGE & ADMINISTRATION

    Directions:

    Apply as often as necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    None.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART COCOA BUTTER PETROLEUM JELLY

    NET WT. 8OZ. (226G)

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART COCOA BUTTER PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-014
    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) 0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-014-1950 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    2NDC:52862-014-20100 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    3NDC:52862-014-14113 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    4NDC:52862-014-21170 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    5NDC:52862-014-01226 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    6NDC:52862-014-22283 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    7NDC:52862-014-23368 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    8NDC:52862-014-24425 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    9NDC:52862-014-25450 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    10NDC:52862-014-26500 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/28/2013
    Labeler - Home Smart Products (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-014)
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