803a-baby Petroleum Jelly_13 Oz

803a-baby Petroleum Jelly_13 Oz
SPL v2
SPL
SPL Set ID 2008da4f-3c3c-4311-e063-6394a90a81e7
Route
TOPICAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (99.83 g)
Inactive Ingredients
Fragrance 13576

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Active ingredient White Petrolatum, USP (99.83%)


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out wetness
Dosage and Administration

Directions

• change wet and soiled diapers promptly

• cleanse diaper area; allow to dry

• apply product liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Description

Active ingredient White Petrolatum, USP (99.83%)

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50567-7

When using this product avoid contact with eyes.

Section 50569-3

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Section 50570-1

Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

Section 51727-6

fragrance

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active ingredient

White Petrolatum, USP (99.83%)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out wetness
Dosage and Administration (34068-7)

Directions

• change wet and soiled diapers promptly

• cleanse diaper area; allow to dry

• apply product liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 50569-3 (50569-3)

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Section 50570-1 (50570-1)

Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

Section 51727-6 (51727-6)

fragrance

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active ingredient

White Petrolatum, USP (99.83%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)