Label: SOFSKIN BABY- mineral oil oil

  • 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. 
    Baby Oil

    Drug Facts:

  • Active Ingredients: 

    Mineral Oil 100%  

    Fragrance Q.S

  • Purpose:       

    Skin protectant, Keeps skin moist and prevents from drying skin.

  • USES: 

    Use after Shower or bath on wet skin as a skin moisturizer. Also use as Eye makeup remover. Helps soften dry skin.

  • Warnings: For external use only.  

    When using this product,avoid contact with eyes.

  • Keep out of the reach of

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

  • Directions: 

    Apply product liberally, as often as necessary

                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
    Oil
    Aceite de Bebe
    Mild & Safe
    For all your moisturizing needs
    7fl. Oz. (200ml)
    7 ONZAS

    Principal Display Panel Sofskin Baby Oil 7 fl. oz. (200ml)

  • INGREDIENTS AND APPEARANCE
    SOFSKIN BABY 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52069-102-07200 mL in 1 BOTTLE
    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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