VITAMINS A AND D WITHOUT LANOLIN- 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(in Each Gram)

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 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


Other Information


Inactive Ingredients


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



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)

Revised: 1/2022
Document Id: d4baf394-1ad5-487f-e053-2995a90a1477
Set id: 28cfe3b6-4d4a-4597-8d2c-b3d703e7091e
Version: 5
Effective Time: 20220103
 
Sion Biotext Medical Ltd