570-3126 Vitamins A&d Ointment Ndc 0404-0168

570-3126 Vitamins A&d Ointment Ndc 0404-0168
SPL v4
SPL
SPL Set ID eb00264f-e73d-771b-e053-2a95a90a85e5
Route
TOPICAL
Published
Effective Date 2022-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
White Petrolatum (93 g)
Inactive Ingredients
Lanolin Light Mineral Oil Vitamin D Vitamin A

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-07

Description

White Petrolatum 93% w/w

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

White Petrolatum 93% w/w

Label

Vitamins A&D Ointment

Use(s)

• Helps treat chafed skin associated with diaper rash

• Helps seal out wetness

• Temporarily protects minor • Cuts • Scrapes • Burns

• Temporarily helps protect and relieve chapped and cracked skin and lips

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

Warnings

For External Use Only

Directions

• Apply as needed

• 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, and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Do Not Use On

• Deep or puncture wounds

• Animal bites

• Serious burns

Active Ingredient

White Petrolatum 93% w/w

Other Information

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

• Avoid excessive heat and humidity

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

Inactive Ingredients

Lanolin, Light Mineral Oil, Vitamin A, Vitamin D

When Using This Product

Do not get into eyes

Stop Use and Ask A Doctor If

• The condition persists or gets worse

• 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 (1-800-222-1222) right away.


Structured Label Content

Label

Vitamins A&D Ointment

Use(s)

• Helps treat chafed skin associated with diaper rash

• Helps seal out wetness

• Temporarily protects minor • Cuts • Scrapes • Burns

• Temporarily helps protect and relieve chapped and cracked skin and lips

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

Purpose

Skin Protectant

Warnings

For External Use Only

Directions

• Apply as needed

• 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, and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Do Not Use On (Do not use on)

• Deep or puncture wounds

• Animal bites

• Serious burns

Active Ingredient

White Petrolatum 93% w/w

Other Information

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

• Avoid excessive heat and humidity

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

Inactive Ingredients

Lanolin, Light Mineral Oil, Vitamin A, Vitamin D

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)

• The condition persists or gets worse

• 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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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