43473-090, Talwax Vitamins Ad Ointment

SPL v1

SPL

SPL Set ID 333fdce4-5a1d-45a4-94fe-81d47ecd2670

Route

TOPICAL

Published

Effective Date 2025-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (76 g)

Inactive Ingredients

Mineral Oil Microcrystalline Wax Paraffin Vitamin A Vitamin D

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-04

Description

Active ingredient White Petroletum, 76% w/w

Medication Information

Warnings and Precautions

Warnings

Do not use on: Deep or puncture wounds, animal bites, and/or seruious burns

When using this product, do not get into eyes

Stop useand ask doctor if condition worsens, symptom lasts more than 7 days

Indications and Usage

Uses

Temporarily protect minor cuts, scrapes, burns

Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips

Helps provent and protect from the drying effects of wind and cold weather

Helps treat chafed skin associated with diaper rash

Dosage and Administration

Directions

Apply as needed

Description

Active ingredient White Petroletum, 76% w/w

Section 44425-7

Other information

Store at room temperature 15-30C (59-86F)

Avoid excessive heat and humidity

Section 50565-1

Keep out of reach of children. If swallowed, get medical help right away

Section 51727-6

Inactive ingredients

Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A, Vitamin D

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active ingredient

White Petroletum, 76% w/w

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily protect minor cuts, scrapes, burns

Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips

Helps provent and protect from the drying effects of wind and cold weather

Helps treat chafed skin associated with diaper rash

Dosage and Administration (34068-7)

Directions

Apply as needed

Warnings and Precautions (34071-1)

Warnings

Do not use on: Deep or puncture wounds, animal bites, and/or seruious burns

When using this product, do not get into eyes

Stop useand ask doctor if condition worsens, symptom lasts more than 7 days

Section 44425-7 (44425-7)

Other information

Store at room temperature 15-30C (59-86F)

Avoid excessive heat and humidity

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help right away

Section 51727-6 (51727-6)

Inactive ingredients

Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A, Vitamin D

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

White Petroletum, 76% w/w

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN A", "unii": "81G40H8B0T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN D", "unii": "9VU1KI44GP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "76", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Temporarily protect minor cuts, scrapes, burns Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips Helps provent and protect from the drying effects of wind and cold weather Helps treat chafed skin associated with diaper rash", "34068-7": "Directions Apply as needed", "34071-1": "Warnings Do not use on: Deep or puncture wounds, animal bites, and/or seruious burns When using this product, do not get into eyes Stop useand ask doctor if condition worsens, symptom lasts more than 7 days", "44425-7": "Other information Store at room temperature 15-30C (59-86F) Avoid excessive heat and humidity", "50565-1": "Keep out of reach of children . If swallowed, get medical help right away", "51727-6": "Inactive ingredients Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A, Vitamin D", "55105-1": "Purpose Skin Protectant", "55106-9": "Active ingredient White Petroletum, 76% w/w"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:58.655932 · Updated: 2026-03-14T23:13:29.977510