OTC Medication Information: Vitamin A D

VITAMIN A D- petrolatum ointment
Sion Biotext Medical Ltd.

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 0 C to 30 0 C (59 0 — 86 0 F)
  • 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
(click image for full-size original)

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
(click image for full-size original)

NDC 68786-213-03

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

12 tubes

Net Wt 4 oz (113 g)

IMAGE 3
(click image for full-size original)

NDC 68786-213-04

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

1 tube

Net Wt 4 oz (113 g)

IMAGE 4
(click image for full-size original)

NDC 68786-213-05

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

144 Packets

0.18 oz (5 g)

IMAGE 5
(click image for full-size original)
VITAMIN A D
white petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68786-213
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 0.93 g in 1 g
Inactive Ingredients
Ingredient Name Strength
VITAMIN A
VITAMIN D
LANOLIN
LIGHT MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68786-213-01 6 BOX in 1 CASE contains a BOX
1 144 PACKET in 1 BOX This package is contained within the CASE (68786-213-01) and contains a PACKET
1 5 g in 1 PACKET This package is contained within a BOX and a CASE (68786-213-01)
2 NDC:68786-213-02 18 BOX in 1 CASE contains a BOX
2 4 PACKET in 1 BOX This package is contained within the CASE (68786-213-02) and contains a PACKET
2 113 g in 1 PACKET This package is contained within a BOX and a CASE (68786-213-02)
3 NDC:68786-213-03 6 BOX in 1 CASE contains a BOX
3 12 PACKET in 1 BOX This package is contained within the CASE (68786-213-03) and contains a PACKET
3 113 g in 1 PACKET This package is contained within a BOX and a CASE (68786-213-03)
4 NDC:68786-213-04 56 BOX in 1 CASE contains a BOX
4 1 TUBE in 1 BOX This package is contained within the CASE (68786-213-04) and contains a TUBE
4 113 g in 1 TUBE This package is contained within a BOX and a CASE (68786-213-04)
5 NDC:68786-213-05 6 BOX in 1 CASE contains a BOX
5 144 PACKET in 1 BOX This package is contained within the CASE (68786-213-05) and contains a PACKET
5 5 g in 1 PACKET This package is contained within a BOX and a CASE (68786-213-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 02/14/2017
Labeler — Sion Biotext Medical Ltd. (532775194)
Registrant — Sion Biotext Medical Ltd. (532775194)

Revised: 01/2024 Sion Biotext Medical Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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