Label: SOFSKIN BABY- 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 March 8, 2010

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  • SPL UNCLASSIFIED SECTION

    Label for

    NOVA PETROLEUM & CHEMICALS CORP.

    Sofskin Baby Petroleum Jelly

    Drug Facts:

  • Active Ingredients:  

    White Petroleum (USP) 100%

    Fragrance, Q.S.

  • Purpose:

    Skin protectant

  • USES:

    helps treat and prevent diaper rash. Help seal out wetness

  • WARNING:

    For external use only.

    Do not apply over deep puncture wounds.

    Infections or lacerations. If redness or swelling develops consult a physician promptly. Keep out of reach of children. If swallowed get medical help or contact Poison control center right away.

  • DIRECTION:

    Apply liberally to clean, dry diaper area

                Made in India

    Imported by:

          Nova Petroleum & Chemicals Corp.

          3 Roethal Drive Suite 1 D

          Hopewell Junction, NY 12533

          www.novawax.com

    Distributed by:

          Vini Health and Beauty Products Inc.

          3 Roethal Drive Suite 1 D

          Hopewell Junction, NY 12533

  • Principal Display Panel

    Sofskin 
    Baby
    Jelly
    Net Wt. 225g (8 Oz)

    Principal Display Panel Sofskin Baby Jelly Net Wt. 225g (8 Oz)

  • INGREDIENTS AND APPEARANCE
    SOFSKIN BABY 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM225 g  in 225 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52069-103-08225 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/10/2010
    Labeler - Nova Petroleum & Chemicals Corporation (831871731)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kim Chemicals LTD650470164MANUFACTURE
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