Otc - Active Ingredient
Zinc Oxide 25%
Baby Diaper Rash Cream
FDA Label NDC 71630-549
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doterra International, Llc for the product Baby Diaper Rash Cream (NDC 71630-549). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin protectant
Indications & Usage
Uses
• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash and
helps seal out wetness
Warnings
For external use only.
Otc - When Using
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 a Poison Control Center immediately.
Other Safety Information
Other information
• Store between 20° to 25°C (68° to 77°F)
• Do not use if quality seal is broken
Inactive Ingredient
Inactive ingredients: Caprylic/Capric Triglyceride, Simmondsia chinensis
(Jojoba) Seed Oil, Beeswax (Cera Alba),
Butyrospermum parkii (Shea) Butter, Carthamus
tinctorius (Safflower) Oleosomes, Water (Aqua),
Caprylyl Glycol, Lavandula angustifolia (Lavender)
Oil, Daucus carota sativa (Carrot) Seed Oil,
Melaleuca alternifolia (Tea Tree) Leaf Oil
Otc - Questions
Questions? Call 1-800-411-8151
Dosage & Administration
Active ingredient Purpose
Zinc Oxide 25%...........................Skin Protectant
Directions
• Change wet or soiled diapers promptly
• Cleanse the diaper area and allow to dry
• Apply cream liberally as often as necessary with
each diaper change especially at bedtime or any
time exposure to wet diapers may be prolonged
Principal Display Panel And Package Label
doTERRA® baby
Diaper Rash Cream
Helps Treat, Soothe, and Prevent Diaper Rash
Net wt. 2.1 oz/60 g
* Please review the disclaimer below.
