Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 17557be8-a463-4b6a-99a2-82fcc5a8c61a
Route
TOPICAL
Published
Effective Date 2012-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (99.9 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-10-31

Description

White Petroleum 99.9%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

White Petroleum 99.9%

Uses
  • temporarily protects minor cuts, scrapes or burns.
  • temporarily protects and helps relieve chapped or cracked skin and lips.
  • helps protect from the drying effects of wind and cold weather.
  • helps treat and prevent diaper rash
  • helps seal out wetness
Warnings

For External Use Only.

  • When using this product do not get into eyes.
Directions
  • Apply as needed
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

White Petroleum 99.9%

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

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


Structured Label Content

Uses
  • temporarily protects minor cuts, scrapes or burns.
  • temporarily protects and helps relieve chapped or cracked skin and lips.
  • helps protect from the drying effects of wind and cold weather.
  • helps treat and prevent diaper rash
  • helps seal out wetness
Purpose

Skin protectant

Warnings

For External Use Only.

  • When using this product do not get into eyes.
Directions
  • Apply as needed
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

White Petroleum 99.9%

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)

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


Advanced Ingredient Data


Raw Label Data

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