Label: NUVALU PETROLEUM COCOA BUTTER- 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 November 22, 2018

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  • Drug Facts Active Ingredient

    White Petrolatum USP (99.9 percent)

  • Purpose

    Skin protectant

  • Use

    Helps treat and prevent diaper rash

    Petroleum jelly restores smooth and healthy skin

    Helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind

    For the temporary protection of minor cuts, scrapes, burns and sunburn

  • Warnings:

    For external use only

    Avoid contact with eyes

  • Stop use and ask a doctor if

    condition worsens or does not improve after 7 days

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally, as often as necessary.

  • Inactive ingredient:

    fragrance

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    NUVALU PETROLEUM COCOA BUTTER 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72520-110
    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:72520-110-24170 g in 1 JAR; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2018
    Labeler - JC SALES (610969578)
    Registrant - JC SALES (610969578)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(72520-110)
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