VITAMIN A D- white petrolatum ointment 
Sion Biotext Medical Ltd.

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.

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Drug Facts

Active Ingredient

White Petrolatum USP (93% w/w)          

Purpose

Skin Protectant

Uses

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

Other information:

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

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)

Revised: 1/2022
Document Id: d4ba5711-78e1-a448-e053-2a95a90aef4d
Set id: 503c4ab9-1f60-48e2-af47-7ef996466a5b
Version: 4
Effective Time: 20220103
 
Sion Biotext Medical Ltd.