Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID 503c4ab9-1f60-48e2-af47-7ef996466a5b

Route

TOPICAL

Published

Effective Date 2019-01-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Petrolatum (0.93 g)

Inactive Ingredients

Vitamin A Vitamin D Lanolin Light Mineral Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-02-14

Description

White Petrolatum USP (93% w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP (93% w/w)

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

Directions

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

Do Not Use On

Deep puncture or wounds
Animal bites
Serious burns

Active Ingredient

White Petrolatum USP (93% w/w)

Other Information:

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

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)

NDC 68786-213-03

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

12 tubes

Net Wt 4 oz (113 g)

NDC 68786-213-04

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

1 tube

Net Wt 4 oz (113 g)

NDC 68786-213-05

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

144 Packets

0.18 oz (5 g)

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

Keep Out of Reach of Children

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

Structured Label Content

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

Purpose

Skin Protectant

Warnings:

For External Use Only

Directions

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

Do Not Use On (Do not use on)

Deep puncture or wounds
Animal bites
Serious burns

Active Ingredient

White Petrolatum USP (93% w/w)

Other Information: (Other information:)

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

Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel (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)

NDC 68786-213-03

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

12 tubes

Net Wt 4 oz (113 g)

NDC 68786-213-04

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

1 tube

Net Wt 4 oz (113 g)

NDC 68786-213-05

Vitamins A&D Ointment

Diaper Rash Ointment

Skin Protectant

Made in Israel

144 Packets

0.18 oz (5 g)

When Using This Product (When using this product)

Do not get into eyes

Stop Use and Ask A Doctor If (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

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

Advanced Ingredient Data

[{"name": "VITAMIN A", "unii": "81G40H8B0T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN D", "unii": "9VU1KI44GP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "0.93", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Skin Protectant", "Warnings:": "For External Use Only", "Directions": "Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply as needed", "Do not use on": "Deep puncture or wounds Animal bites Serious burns", "Active Ingredient": "White Petrolatum USP (93% w/w) ", "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) 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) NDC 68786-213-03 Vitamins A&D Ointment Diaper Rash Ointment Skin Protectant Made in Israel 12 tubes Net Wt 4 oz (113 g) NDC 68786-213-04 Vitamins A&D Ointment Diaper Rash Ointment Skin Protectant Made in Israel 1 tube Net Wt 4 oz (113 g) NDC 68786-213-05 Vitamins A&D Ointment Diaper Rash Ointment Skin Protectant Made in Israel 144 Packets 0.18 oz (5 g)", "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", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:44.503235 · Updated: 2026-03-14T23:14:10.164520