SPL v3
SPL
SPL Set ID 40f5713e-3c9b-3edd-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (99.9 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-10
Description

White Petrolatum (99.9% w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum (99.9% w/w)

Uses
  • temporarily protects minor cuts, scrapes, burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from effects of wind and cold weather
  • helps treat and prevent diaper rash
  • helps seal out wetness
Section 51945-4

Warnings
  • FOR EXTERNAL USE ONLY
Directions

apply as needed

Do Not Use On
  • deep or puncture wounds
  • animal bites or serious burns
Active Ingredient

White Petrolatum (99.9% w/w)

Inactive Ingredient

Fragrance

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few day
Keep Out of Reach of Children

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

Structured Label Content

Uses
  • temporarily protects minor cuts, scrapes, burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from effects of wind and cold weather
  • helps treat and prevent diaper rash
  • helps seal out wetness
Section 51945-4 (51945-4)

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 or serious burns
Active Ingredient

White Petrolatum (99.9% w/w)

Inactive Ingredient

Fragrance

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 for more than 7 days or clear up and occur again within a few day
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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:02.675368 · Updated: 2026-03-14T22:55:55.934342