570-3127 Petrolatum Ointment Ndc0404-0169-50

570-3127 Petrolatum Ointment Ndc0404-0169-50
SPL v4
SPL
SPL Set ID eb7a5698-754e-4e46-e053-2a95a90a57b4
Route
TOPICAL
Published
Effective Date 2022-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
White Petrolatum (1 g)

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-17

Description

White Petrolatum 100%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

White Petrolatum 100%

Label

570-3127 Petrolatum Ointment

Use(s)

• Temporarily protects minor cuts, scrapes, and burns

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

• Helps prevent and protect from the drying effects of wind and cold weather

• Protects chafed skin due to diaper rash

Warnings

For External Use Only

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

• For other uses: Apply as needed.

Do Not Use On

• Deep or puncture wounds

• Animal bites

• Serious burns

Active Ingredient

White Petrolatum 100%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper evident. Do not use if packet is torn, cut, or opened.

When Using This Product

Avoid contact with eyes

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 (1-800-222-1222) right away.


Structured Label Content

Label

570-3127 Petrolatum Ointment

Use(s)

• Temporarily protects minor cuts, scrapes, and burns

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

• Helps prevent and protect from the drying effects of wind and cold weather

• Protects chafed skin due to diaper rash

Purpose

Skin Protectant

Warnings

For External Use Only

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

• For other uses: Apply as needed.

Do Not Use On (Do not use on)

• Deep or puncture wounds

• Animal bites

• Serious burns

Active Ingredient

White Petrolatum 100%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper evident. Do not use if packet is torn, cut, or opened.

When Using This Product (When using this product)

Avoid contact with 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 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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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