Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID ef89a68a-74c1-4c42-8078-b7a208ace0de
Route
TOPICAL
Published
Effective Date 2023-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.97 g)
Inactive Ingredients
Lavender Oil Cod Liver Oil Lanolin Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-19

Description

White Petrolatum 97%


Medication Information

Warnings and Precautions

For external use only.

When using this productdo not get into eyes

Do not use on:

Deep or puncture wounds

Animal bites

Serious burns

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

Indications and Usage

Temporarily protects minor cuts, scrapes and burns

Temporarily protects and helps relieve chapped, chafed or cracked skin and lips

Helps protect from the drying effects of wind and cold weather

Helps treat and prevent diaper rash.  Protects chafed skin associated with diaper rash and helps seal out wetness

Dosage and Administration

For skin protectant useapply as needed

For diaper rash use:

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Description

White Petrolatum 97%

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Cod Liver Oil (Contains Vitamin A and D), Lanolin, Lavendar Oil, Light Liquid Paraffin, Liquid Paraffin, Vitamin A, Vitamin D, White Petolatum

Section 51945-4

Section 55105-1

Skin Protectant

Active Ingredient

White Petrolatum 97%


Structured Label Content

Indications and Usage (34067-9)

Temporarily protects minor cuts, scrapes and burns

Temporarily protects and helps relieve chapped, chafed or cracked skin and lips

Helps protect from the drying effects of wind and cold weather

Helps treat and prevent diaper rash.  Protects chafed skin associated with diaper rash and helps seal out wetness

Dosage and Administration (34068-7)

For skin protectant useapply as needed

For diaper rash use:

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Warnings and Precautions (34071-1)

For external use only.

When using this productdo not get into eyes

Do not use on:

Deep or puncture wounds

Animal bites

Serious burns

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

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Cod Liver Oil (Contains Vitamin A and D), Lanolin, Lavendar Oil, Light Liquid Paraffin, Liquid Paraffin, Vitamin A, Vitamin D, White Petolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Active Ingredient (ACTIVE INGREDIENT)

White Petrolatum 97%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)