VITAMIN A D (WHITE PETROLATUM) OINTMENT [SION BIOTEXT MEDICAL LTD.]

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VITAMIN A D (WHITE PETROLATUM) OINTMENT [SION BIOTEXT MEDICAL LTD.]
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NDC 68786-213-01, 68786-213-02, 68786-213-03
Set ID 503c4ab9-1f60-48e2-af47-7ef996466a5b
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredient

    White Petrolatum USP (93% w/w)          

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor * cuts * scrapes * burns
    • Temporarily helps protect and help relieve chapped and cracked skin and lips
    • Helps prevent and protect from the drying effects of wind and cold weather
    • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
    • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
  • 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 puncture or 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

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply as needed
  • Other information:

    • Store at controlled room temperature 150C to 300C (590- 860F)
    • Avoid excessive heat and humidity
    • Tamper Evident. Do not use if packet is torn, cut or open.
  • Inactive Ingredients

    Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

  • Principal Display panel

    NDC 68786-213-01

    Vitamins A&D Ointment

    Intensive Moisturizer for Skin Therapy

    For Personal and Professional Use

    SION MEDICAL

    Made in Israel

    144 Packets

    Net Wt. 0.17oz(5g)

    Label 1

    NDC 68786-213-02

    Vitamins A&D Ointment

    Intensive Moistuirzer for Skin Therapy

    For Personal and Professional Use

    SION MEDICAL

    Made in Israel

    4 tubes

    Net Wt 4 oz (113 g)

    Label 2

  • INGREDIENTS AND APPEARANCE
    VITAMIN A D 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.93 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-213-016 in 1 CASE02/14/2017
    1144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68786-213-0218 in 1 CASE02/14/2017
    24 in 1 BOX
    2113 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:68786-213-036 in 1 CASE01/31/2019
    312 in 1 BOX
    3113 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/14/2017
    Labeler - Sion Biotext Medical Ltd. (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd.532775194manufacture(68786-213)
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