VITAMINS A AND D WITHOUT LANOLIN (WHITE PETROLATUM) OINTMENT [SION BIOTEXT MEDICAL LTD]

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VITAMINS A AND D WITHOUT LANOLIN (WHITE PETROLATUM) OINTMENT [SION BIOTEXT MEDICAL LTD]
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NDC 68786-411-01
Set ID 28cfe3b6-4d4a-4597-8d2c-b3d703e7091e
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART346
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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 CASE
    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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