VITAMIN A D- 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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Vitamin A D

Active Ingredient                               Purpose

White Petrolatum USP (75%)            Skin Protectant

Uses: Vitamin AD

  • 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

Do Not Get In Eyes

Stop use and ask a doctor if:

  • If condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days

Do not use on:

Do not use on:


  • Deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions for diaper rash:

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

Other information:

  • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
  • Avoid excessive heat
  • Tamper Evident. Do not use if packet is torn, cut or open.

Inactive Ingredients

Inactive Ingredients: Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Indications and Usage

Indications and Usage

A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.

Principal Display Panel

Sion Biotext Medical Ltd

SBM Vitamin AD.jpg

Label

VITAMIN A D 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.75 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-212-016 in 1 CASE07/09/201212/31/2013
1144 in 1 BOX
15 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:68786-212-026 in 1 CASE07/09/201212/31/2013
212 in 1 BOX
2113.6 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:68786-212-0372 in 1 CASE07/09/201212/31/2013
3113.6 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:68786-212-0412 in 1 CASE07/09/201212/31/2013
4426 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/09/201212/31/2013
Labeler - Sion Biotext Medical Ltd. (532775194)

Revised: 2/2018
 
Sion Biotext Medical Ltd.