Petrocort Antipruritic Lip Balm #21

Petrocort Antipruritic Lip Balm #21
SPL v2
SPL
SPL Set ID 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b
Route
TOPICAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.005 g)
Inactive Ingredients
Petrolatum C18-36 Acid Triglyceride Padimate O Mineral Oil Propylparaben Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-26
Description

Hydrocortisone 0.5%

Purpose

For relief of minor skin irritation.

Medication Information

Purpose

For relief of minor skin irritation.

Description

Hydrocortisone 0.5%

Uses:

Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

Warnings:

For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat.

Directions:

Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

Package Labeling:

Inactive Ingredients:

Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.

Keep Out of Reach of Children.

Active Ingredient (in Percentage)

Hydrocortisone 0.5%

Structured Label Content

Uses: (USES:)

Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

Purpose

For relief of minor skin irritation.

Warnings: (WARNINGS:)

For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat.

Directions: (DIRECTIONS:)

Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

Package Labeling:

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredient (in Percentage) (Active Ingredient (in percentage))

Hydrocortisone 0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:30.375977 · Updated: 2026-03-14T23:02:06.847821