Petrolatum Jelly

Petrolatum Jelly
SPL v5
SPL
SPL Set ID 0c6474ed-2343-d5f2-e063-6394a90a30b3
Route
TOPICAL
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-13
Description

White Petrolatum (USP, 100% w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum (USP, 100% w/w)

Uses:
  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and relieve chapped and cracked skin or lips
  • 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 puncture wounds
  • animal bites
  • serious burns.

Active Ingredient

White Petrolatum (USP, 100% w/w)

Other Information
  • Store at 59-86°F (15-30°C)
  • Avoid excessive heat
  • Do not use is package is damaged
Inactive Ingredients

None

Principal Display Panel

DawnMist NDC 65517-2023-1

WHITE PETROLATUM

SKIN PROTECTANT

5gm (.18oz)

Principle Display Panel

DawnMist

WHITE PETROLATUM

SKIN PROTECTANT

NDC 65517-2023-2

Dukal 1oz (28g)

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 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.

Structured Label Content

Uses:
  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and relieve chapped and cracked skin or lips
  • 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 puncture wounds
  • animal bites
  • serious burns.

Active Ingredient

White Petrolatum (USP, 100% w/w)

Other Information
  • Store at 59-86°F (15-30°C)
  • Avoid excessive heat
  • Do not use is package is damaged
Inactive Ingredients

None

Principal Display Panel

DawnMist NDC 65517-2023-1

WHITE PETROLATUM

SKIN PROTECTANT

5gm (.18oz)

Principle Display Panel

DawnMist

WHITE PETROLATUM

SKIN PROTECTANT

NDC 65517-2023-2

Dukal 1oz (28g)

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 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:37.728381 · Updated: 2026-03-14T23:05:30.485285