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Vitamin A D by Sion Biotext Medical Ltd.

Medically reviewed on February 13, 2017

Dosage form: ointment
Ingredients: PETROLATUM .93g in 1g
Labeler: Sion Biotext Medical Ltd.
NDC Code: 68786-213

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 Facts

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)

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)

VITAMIN A D 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-213
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM.93 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN A 
VITAMIN D 
LANOLIN 
LIGHT MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:68786-213-016 BOX in 1 CASE
1144 PACKET in 1 BOX
15 g in 1 PACKET
2NDC:68786-213-0218 BOX in 1 CASE
24 PACKET in 1 BOX
2113 g in 1 PACKET
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/FEIOperations
Sion Biotext Medical Ltd.532775194manufacture(68786-213)

 
Sion Biotext Medical Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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