Dr. Max's Diaper Ointment (85453-101)

Dr. Max's Diaper Ointment (85453-101)
SPL v1
SPL
SPL Set ID 31bfa962-5e3b-c5d2-e063-6294a90ac177
Route
TOPICAL
Published
Effective Date 2025-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (12 g)
Inactive Ingredients
Calendula Officinalis Flower Tocopherol Chamomile Beeswax Ricinus Communis (castor) Seed Oil Olea Europaea (olive) Fruit Oil Helianthus Annuus (sunflower) Seed Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-04

Description

ZINC OXIDE 12%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

ZINC OXIDE 12%

Uses

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact poison control right away.

Section 50566-9

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 51945-4

Warnings

For external use only.

When using this product do not get into eyes.

Directions

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 maybe prolonged.

Questions?
Other Information

Store at 20-30 °C (68-86 °F)

Active Ingredients

ZINC OXIDE 12%

Inactive Ingredients



Ricinus Communis (Castor) Seed Oil, Cera Alba/Beeswax/Cire d'Abeille, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Wax, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol.


Structured Label Content

Uses (USES)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact poison control right away.

Section 50566-9 (50566-9)

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 51945-4 (51945-4)

Purpose (PURPOSE)

Skin Protectant

Warnings (WARNINGS)

For external use only.

When using this product do not get into eyes.

Directions (DIRECTIONS)

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 maybe prolonged.

Questions? (QUESTIONS?)
Other Information (OTHER INFORMATION)

Store at 20-30 °C (68-86 °F)

Active Ingredients (ACTIVE INGREDIENTS)

ZINC OXIDE 12%

Inactive Ingredients (INACTIVE INGREDIENTS)



Ricinus Communis (Castor) Seed Oil, Cera Alba/Beeswax/Cire d'Abeille, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Wax, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol.


Advanced Ingredient Data


Raw Label Data

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