SPL v2
SPL
SPL Set ID 3eddf0e7-8e9d-a311-e063-6394a90ad156
Route
TOPICAL
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
White Petrolatum (100 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01
Description

White Petrolatum USP, 100%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP, 100%

Uses
  • Temporarily protects minor: cuts, scrapes, burns
  • Temporarily protects chafed, chapped or cracked skin
  • Helps protect against the drying effects of wind and cold weather
  • Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness
Section 51727-6

None

Section 51945-4

Warnings

Warnings

For external use only

Directions

Directions

  • As a skin protectant: apply as needed
  • For diaper rash: Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply jelly liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Do Not Use On

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

White Petrolatum USP, 100%

When Using This Product

When using this product do not get into the 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. In case of accidental ingestion contact a physician or Poison Control Center right away.

Structured Label Content

Uses
  • Temporarily protects minor: cuts, scrapes, burns
  • Temporarily protects chafed, chapped or cracked skin
  • Helps protect against the drying effects of wind and cold weather
  • Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness
Section 51727-6 (51727-6)

None

Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

Warnings

For external use only

Directions

Directions

  • As a skin protectant: apply as needed
  • For diaper rash: Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply jelly liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Do Not Use On (Do not use on)

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

White Petrolatum USP, 100%

When Using This Product (When using this product)

When using this product do not get into the eyes

Stop Use and Ask A Doctor If (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)

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.159438 · Updated: 2026-03-14T23:10:48.259693