FDA.reportPublic FDA data

Vitamin A D

Manufacturer
Sion Biotext Medical Ltd.
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:49:24

Label at a glance#

ProductVitamin A D
Active ingredientPETROLATUM
Label structure8 sections

Indications and 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 t...

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (93% w/w)          

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • 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

OTC - DO NOT USE SECTION

  • Deep puncture or wounds
  • Animal bites
  • Serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information:

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15 0C to 30 0C (59 0- 86 0F)
  • Avoid excessive heat and humidity
  • Tamper Evident. Do not use if packet is torn, cut or open.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display panel

PACKAGE LABEL.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 1Label 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 2Label 2

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 3IMAGE 3

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 4IMAGE 4

NDC 68786-213-05

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

144 Packets

0.18 oz (5 g)

IMAGE 5IMAGE 5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1440181petrolatum 93 % Topical OintmentPSN9
1440181petrolatum 0.93 MG/MG Topical OintmentSCD9
1440181petrolatum 93 % Topical OintmentSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-213-01Vitamin A D6 in 1 CASEOINTMENT69
68786-213-01Vitamin A D144 in 1 BOXOINTMENT1449
68786-213-02Vitamin A D18 in 1 CASEOINTMENT189
68786-213-02Vitamin A D4 in 1 BOXOINTMENT49
68786-213-03Vitamin A D12 in 1 BOXOINTMENT129
68786-213-03Vitamin A D6 in 1 CASEOINTMENT69
68786-213-04Vitamin A D56 in 1 CASEOINTMENT569
68786-213-04Vitamin A D1 in 1 BOXOINTMENT19
68786-213-05Vitamin A D144 in 1 BOXOINTMENT1449
68786-213-05Vitamin A D6 in 1 CASEOINTMENT69

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68786-21368786-213-01, 68786-213-02, 68786-213-03, 68786-213-04, 68786-213-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-01-08monthly-update2026-06-03 17:51:45
72024-01-24full-release2026-06-01 00:07:49

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
ndc (package): 68786-213-04
ndc (package): 68786-213-01
ndc (package): 68786-213-03
ndc (package): 68786-213-05
ndc (package): 68786-213-02
ndc (product): 68786-213
ndc11 (package): 68786021305
ndc11 (package): 68786021304
ndc11 (package): 68786021303
ndc11 (package): 68786021301
ndc11 (package): 68786021302
spl id: 4c9d7f9a-6e37-d92e-e063-6394a90aeac0
spl set id: 503c4ab9-1f60-48e2-af47-7ef996466a5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.