FDA.reportPublic FDA data

Vitamins A and D without Lanolin

Manufacturer
Sion Biotext Medical Ltd
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:24

Label at a glance#

ProductVitamins A and D without Lanolin
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

Temporarily protects minor Cuts Scrapes Burns Temporarily helps protect and helps relieve chapped and cracked skin or lips Helps prevent and protect from drying effects of wind and cold weather Temporarily protects and helps relieve minor skin irritation and itching due to: Rashes Eczema

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active Ingredient(in Each Gram)

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum, USP, 93% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION


  • Temporarily protects minor
  • Cuts
  • Scrapes
  • Burns

  • Temporarily helps protect and helps relieve chapped and cracked skin or lips
  • Helps prevent and protect from drying effects of wind and cold weather
  • Temporarily protects and helps relieve minor skin irritation and itching due to:
  • Rashes
  • Eczema

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 - STOP USE 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 or puncture 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


  • Apply as needed

Other Information

SPL UNCLASSIFIED SECTION


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

Inactive Ingredients

INACTIVE INGREDIENT SECTION


  • Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

PACKAGE LABEL.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

LabelLabel



DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1440181petrolatum 93 % Topical OintmentPSN6
1440181petrolatum 0.93 MG/MG Topical OintmentSCD6
1440181petrolatum 93 % Topical OintmentSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68786-411-012024-01-30C16284748780-19d75b9d1-0e3a-f424-e053-dadaa90a57ceDrug Facts
68786-411-012022-01-03C16284748780-19d75b9d1-0e3a-f424-e053-dadaa90a57ceDrug Facts
68786-411-012020-01-31C16284748780-19d75b9d1-0e3a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-411-01Vitamins A and D without Lanolin6 in 1 CASEOINTMENT66
68786-411-01Vitamins A and D without Lanolin144 in 1 BOXOINTMENT1446

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-411VITAMINS A AND D WITHOUT LANOLIN (WHITE PETROLATUM) OINTMENT [SION BIOTEXT MEDICAL LTD]6Legacy NDC, 2 package rows20221213_28cfe3b6-4d4a-4597-8d2c-b3d703e7091e.zip

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
68786-41168786-411-01

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
LAVENDER OILZBP1YXW0H8IACT
LIGHT MINERAL OILN6K5787QVPIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

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
efa72e7e-0e55-4183-e053-2a95a90a6bcc28cfe3b6-4d4a-4597-8d2c-b3d703e7091e2022-12-12WarningsExact identifier
spl id: efa72e7e-0e55-4183-e053-2a95a90a6bcc
spl set id: 28cfe3b6-4d4a-4597-8d2c-b3d703e7091e

Reported adverse events (FAERS/openFDA)#

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