Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID bbbca68e-1b65-49b1-a5fa-ed4da55d05e3
Route
TOPICAL
Published
Effective Date 2013-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (93.4 g)
Inactive Ingredients
Solvent Yellow 18 Lanolin Light Mineral Oil Vitamin A Vitamin D

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-12-06
Description

White Petrolatum (USP 93.4% w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum (USP 93.4% w/w)

Uses
  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes and burns
  • Temporarily helps protect and helps relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Warnings

For External Use Only.

Directions
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply as needed

Do Not Use On
  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Other Information
  • Store at room temperature 150 - 300 c ( 590 - 860 F)
  • Avoid excessive heat and humidity

  • Tamper Evident
  • Do not use if packet it torn, cut or opened.

Inactive Ingredients

CI 17240, Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

When Using This Product
  • Avoid contact with eyes

Stop Use and Ask Doctor If
  • The condition persists or get worse
  • Symptoms last more than 7 days or clear up and occur again in a few days
Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Center right away

Active Ingredients(in Each Gram)

White Petrolatum (USP 93.4% w/w)

Structured Label Content

Uses
  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes and burns
  • Temporarily helps protect and helps relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Purpose

Skin Protectant

Warnings

For External Use Only.

Directions
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply as needed

Do Not Use On (Do not use on)
  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Other Information
  • Store at room temperature 150 - 300 c ( 590 - 860 F)
  • Avoid excessive heat and humidity

  • Tamper Evident
  • Do not use if packet it torn, cut or opened.

Inactive Ingredients

CI 17240, Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

When Using This Product (When using this product)
  • Avoid contact with eyes

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • The condition persists or get worse
  • Symptoms last more than 7 days or clear up and occur again in 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 right away

Active Ingredients(in Each Gram) (Active Ingredients(in each gram))

White Petrolatum (USP 93.4% w/w)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.873805 · Updated: 2026-03-14T23:09:05.302478