drug facts

drug facts

SPL v1

SPL

SPL Set ID 559abce4-cedf-4385-975e-82e6b3bcceba

Route

topical

Published

Effective Date 2013-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

petrolatum (99.98 mg)

Inactive Ingredients

methyl salicylate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph final active Since 2013-05-02

Purpose

Skin Protectant

Description

Petrolatum, 100%

Medication Information

Warnings

For external use only. When using this product –Do not get into eyes. Stop use and ask a doctor if – condition worsens-symptoms last more than 7 days or clear up and occur again within a few days.

Uses

Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.

Purpose

Skin Protectant

Directions

Apply as needed.

Inactive Ingredients

Flavor

Description

Petrolatum, 100%

Active Ingredient

Petrolatum, 100%

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Warnings

Uses

Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.

Purpose

Skin Protectant

Directions

Apply as needed.

Inactive Ingredients

Flavor

Active Ingredient (Active ingredient)

Petrolatum, 100%

Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "99.98", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "0.02", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.", "Purpose": "Skin Protectant", "Warnings": "For external use only. When using this product –Do not get into eyes. Stop use and ask a doctor if – condition worsens-symptoms last more than 7 days or clear up and occur again within a few days.", "Directions": "Apply as needed.", "Active ingredient": "Petrolatum, 100%", "Inactive Ingredients": "Flavor", "Keep Out of Reach of Children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:37.793797 · Updated: 2026-03-14T22:53:29.712463