Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 699639de-1f35-cd89-e053-2a91aa0ad3ff
Route
TOPICAL
Published
Effective Date 2018-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-04-09

Description

White petrolatum USP (100%)

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

White petrolatum USP (100%)

Uses

■ petroleum jelly restores smooth and healthy skin ■ helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind ■ for the temporary protection of minor cuts, scrapes, burns and sunburn ■ helps to treat and prevent diaper rash

Warnings

For external use only

Avoid contact with eyes

Directions

■ apply liberally as often as necessary

Package Label

Active Ingredients

White petrolatum USP (100%)

Stop Use and Ask A Doctor If

■ condition worsens or does not improve after 7 days

Keep Out of Reach of Children

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


Structured Label Content

Uses

■ petroleum jelly restores smooth and healthy skin ■ helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind ■ for the temporary protection of minor cuts, scrapes, burns and sunburn ■ helps to treat and prevent diaper rash

Purpose

Skin protectant

Warnings

For external use only

Avoid contact with eyes

Directions

■ apply liberally as often as necessary

Package Label

Active Ingredients (Active ingredients)

White petrolatum USP (100%)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ condition worsens or does not improve after 7 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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