Label: VITAMIN A D- white petrolatum ointment

  • NDC Code(s): 68786-213-01, 68786-213-02, 68786-213-03
  • Packager: Sion Biotext Medical Ltd.
  • 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 January 3, 2022

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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 15 0C to 30 0C (59 0- 86 0F)
    • 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) PETROLATUM0.93 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)
    Registrant - Sion Biotext Medical Ltd. (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd.532775194manufacture(68786-213)
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