Label: SOFSKIN PETROLEUM- white petroleum 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 6, 2010

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  • SPL UNCLASSIFIED SECTION

    Label for

    NOVA PETROLEUM & CHEMICALS CORP.

    Petroleum jelly

    Drug Facts:

  • Active Ingredients:     

    White Petroleum (USP) 100%   

  • Purpose:

    Skin protectant

  • USES:

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

    Helps protect chafed, chapped, cracked or wind burned skin and lips. 

  • Warnings: 

    For external use only.  

  • Do not use 

    over deep or puncture wounds, infection or laceration, Ask a doctor.

  • If pregnant or breast feeding: 

    Ask a health professional before use.

  • Keep out of reach of children:

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

  • When using this product, 

    avoid contact with eyes.

  • Stop use and ask doctor 

    if condition worsens or does not improve within 7 days.

  • 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
    The Skin Softener
    Petroleum Jelly
    NET WT. 8 OZ. (110g)
    FDA NDC 52069-100-08

    Principal Display Panel Sofskin Petroleum Jelly Net Wt. 8 Oz. (255 g)

  • INGREDIENTS AND APPEARANCE
    SOFSKIN PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM110 g  in 110 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52069-100-08110 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)
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