SPL v3
SPL
SPL Set ID 35c163e6-ae58-2791-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 (100 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-06-21
Description

White Petrolatum USP (100%)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP (100%)

Uses
  • for the temporary protection of minor cuts, scrapes, burns and sunburn
  • helps to temporarily protect chafed , chapped , cracked or windburned skin and lips
Section 51945-4

Warnings:

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Directions
  • apply as needed
Active Ingredient

White Petrolatum USP (100%)

Other Information
  • Store at room temperature
Inactive Ingradients

None

When Using This Product
  • do not get into eyes
Keep Out of Reach of Childen
  • if swalloed , get medical help or contact a Proison Control Center right away
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clean up and occur again in a few days

Structured Label Content

Uses
  • for the temporary protection of minor cuts, scrapes, burns and sunburn
  • helps to temporarily protect chafed , chapped , cracked or windburned skin and lips
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings:

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Directions
  • apply as needed
Active Ingredient

White Petrolatum USP (100%)

Other Information
  • Store at room temperature
Inactive Ingradients

None

When Using This Product (When using this product)
  • do not get into eyes
Keep Out of Reach of Childen (Keep out of reach of childen)
  • if swalloed , get medical help or contact a Proison Control Center right away
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 a few days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:25.725285 · Updated: 2026-03-14T22:59:24.470306