SPL v4
SPL
SPL Set ID 35c163e6-ae41-2791-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-06-21
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 DRUG Active Since 2016-06-21
Description

White Petrolatum USP (99.9% )

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP (99.9% )

Uses
  • helps treat and prevent diaper rash
  • helps seal out wetness
Section 51945-4

Warnings:

Do not use on

  • deep and punture wounds
  • animal bites
  • serious burns
Directions
  • apply liberally to clean out diaper rash area
Active Ingredient

White Petrolatum USP (99.9% )

Other Information
  • Store at room temperature
Inactive Ingredient

Fragrance

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 clean up and occur again in few days
Keep Out of Reach of Children
  • if swallowed, get medical help or contact a Poison Control Center right away

Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • helps seal out wetness
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings:

Do not use on

  • deep and punture wounds
  • animal bites
  • serious burns
Directions
  • apply liberally to clean out diaper rash area
Active Ingredient

White Petrolatum USP (99.9% )

Other Information
  • Store at room temperature
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 more than 7 days or clean up and occur again in 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 right away

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:46.356105 · Updated: 2026-03-14T23:09:44.239716