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SPL v1

SPL

SPL Set ID 21c0b614-ea19-e98d-e063-6294a90ac44e

Route

TOPICAL

Published

Effective Date 2024-09-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (30 g)

Inactive Ingredients

Butylated Hydroxytoluene Panthenol Polyisobutylene (1300 Mw) Microcrystalline Wax Ceresin Yellow Wax Tocopherol Levomenol Sheanut Oil Glycerin Mineral Oil

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-29

Description

Petrolatun 30%

Purpose

Skin Protectant (Ointment)

Medication Information

Purpose

Skin Protectant (Ointment)

Description

Petrolatun 30%

Use

temporarily protects minor;

cut

scrapes

burns

temporarily protects and helps relieve chapped or cracked skin and lips

helps protect from the drying effects of wind and cold weather

Label

Warnings

For external use only

Directions

Apply as needed.

Do Not Use On

deep or puncture wounds

animal bites

serious burns

Active Ingredient

Petrolatun 30%

Other Information

For best product quality, store below 113°F/45°C.

Inactive Ingredients

Mineral Oil

polyisobutene

polyisobutene

beeswax

microcrystalline wax

butyrospermum parkii (shea butter) oil

BHT

Bisabolol

Glycerin

Tocopherol

Panthenol

When Using This Product

When using this product do not get into eyes.

Stop Use and Ask A Doctor If

condition worsens

symptoms last more than 7days or clear up and occur again within 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

Use

temporarily protects minor;

cut

scrapes

burns

temporarily protects and helps relieve chapped or cracked skin and lips

helps protect from the drying effects of wind and cold weather

Label (label)

Purpose

Skin Protectant (Ointment)

Warnings

For external use only

Directions

Apply as needed.

Do Not Use On (Do not use on)

deep or puncture wounds

animal bites

serious burns

Active Ingredient (Active ingredient)

Petrolatun 30%

Other Information (Other information)

For best product quality, store below 113°F/45°C.

Inactive Ingredients (Inactive ingredients)

Mineral Oil

polyisobutene

polyisobutene

beeswax

microcrystalline wax

butyrospermum parkii (shea butter) oil

BHT

Bisabolol

Glycerin

Tocopherol

Panthenol

When Using This Product (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)

condition worsens

symptoms last more than 7days or clear up and occur again within 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": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYISOBUTYLENE (1300 MW)", "unii": "241BN7J12Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SHEANUT OIL", "unii": "O88E196QRF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "temporarily protects minor; cut scrapes burns temporarily protects and helps relieve chapped or cracked skin and lips helps protect from the drying effects of wind and cold weather", "Purpose": "Skin Protectant (Ointment)", "Warnings": "For external use only", "Directions": "Apply as needed.", "Do not use on": "deep or puncture wounds animal bites serious burns", "Active ingredient": "Petrolatun 30%", "Other information": "For best product quality, store below 113°F/45°C.", "Inactive ingredients": "Mineral Oil polyisobutene polyisobutene beeswax microcrystalline wax butyrospermum parkii (shea butter) oil BHT Bisabolol Glycerin Tocopherol Panthenol", "When using this product": "When using this product do not get into eyes.", "Stop use and ask a doctor if": "condition worsens symptoms last more than 7days or clear up and occur again within 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: 2026-02-15T12:03:33.755464 · Updated: 2026-03-14T23:03:41.436909