Active Ingredients
ZINC OXIDE 12%
Dr. Maxs Diaper Ointment
FDA Label NDC 85453-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Max�s Llc for the product Dr. Maxs Diaper (NDC 85453-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps seal out wetness.
Warnings
For external use only.
When using this product do not get into eyes.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact poison control right away.
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.
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.
Other Information
Store at 20-30 °C (68-86 °F)
Questions?
Contact [email protected]
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