Cr-5684410 Leader Petroleum Jelly

SPL v7

SPL

SPL Set ID b9d033f3-4d14-a2c8-e053-2995a90ac7f1

Route

TOPICAL

Published

Effective Date 2021-01-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (100 g)

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-02-15

Description

White Petrolatum 100%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum 100%

Uses

• Temporarily protects minor: cuts, scrapes, and burns

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

• Helps prevent and protect from the drying effects of wind and cold weather

Label

CR-5684428 Label

Warnings

For External Use Only

Directions

Apply as needed

Do Not Use On

• Deep or puncture wounds

• Animal bites

• Serious burns

Active Ingredient

White Petrolatum 100%

Other Information

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

• Avoid excessive heat

Inactive Ingredients

No inactive ingredients

Questions and Comments?

1-888-396-2739

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Uses

• Temporarily protects minor: cuts, scrapes, and burns

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

• Helps prevent and protect from the drying effects of wind and cold weather

Label

CR-5684428 Label

Purpose

Skin Protectant

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

White Petrolatum 100%

Other Information

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

• Avoid excessive heat

Inactive Ingredients

No inactive ingredients

Questions and Comments?

1-888-396-2739

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 7 days 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 (1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• Temporarily protects minor: cuts, scrapes, and burns • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips • Helps prevent and protect from the drying effects of wind and cold weather", "Label": "CR-5684428 Label", "Purpose": "Skin Protectant", "Warnings": "For External Use Only", "Directions": "Apply as needed", "Do not use on": "• Deep or puncture wounds • Animal bites • Serious burns", "Active Ingredient": "White Petrolatum 100%", "Other Information": "• Store at room temperature 59°-86°F (15°-30°C) • Avoid excessive heat", "Inactive Ingredients": "No inactive ingredients", "Questions and Comments?": "1-888-396-2739", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:22.150328 · Updated: 2026-03-14T23:10:44.597675