Label: VITAMINS A AND D WITHOUT LANOLIN- white petrolatum ointment

  • 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 December 12, 2022

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  • Active Ingredient(in Each Gram)

    White Petrolatum, USP, 93% w/w

  • Purpose

    Skin Protectant

  • Uses


    • Temporarily protects minor
    • Cuts
    • Scrapes
    • Burns

    • Temporarily helps protect and helps relieve chapped and cracked skin or lips
    • Helps prevent and protect from drying effects of wind and cold weather
    • Temporarily protects and helps relieve minor skin irritation and itching due to:
    • Rashes
    • Eczema
  • Warnings

    For External Use Only.

    When using this product

    Do not get into eyes

    Stop use and ask a doctor if


    • The condition persists or gets worse
    • Symptoms last more than 7 days or clear up and occur again in a few days

    Do not use on


    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children


    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions


    • Apply as needed
  • Other Information


    • Store at controlled room temperature 15-30 C (59-86 F)
    • Avoid excessive heat and humidity
    • Tamper evident
    • Do not use if packet is torn, cut or opened
  • Inactive Ingredients


    • Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D
  • Principal Display Panel

    NDC 68786-411-01

    Made In Israel

    144 Packets

    SionBiotext Medical Ltd.

    For Professional and Hospital Use

    Vitamin A and D

    Ointment

    without Lanolin

    Ref.: 54J811-5201-000

    Net Wt 5 gram

    Label



  • INGREDIENTS AND APPEARANCE
    VITAMINS A AND D WITHOUT LANOLIN 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM93 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-411-016 in 1 CASE02/11/2016
    1144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/07/2016
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-411)
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