Active Ingredient
Zinc Oxide 40%
Diaperrashointment
FDA Label NDC 68016-128
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Diaperrashointment (NDC 68016-128). 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 ingredient, purpose, uses, keep out of the reach of children., warnings, directions, stop use and ask a doctor if, other information:, 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 due to diaper rash and helps protect skin from wetness
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
For External Use Only
When using this product
- Avoid contact with eyes
Directions
- 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, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Stop Use And Ask A Doctor If
- Condition worsens
- Symptoms last more than 7 days or clear up and occur again with a few days
Other Information:
- Store at controlled room temperature 20° - 25°C (68° - 77°F)
Inactive Ingredients
BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)
Helps Treat And Prevent Diaper Rash. Protects Skin. Relieves Chafing. Promotes Healing
Distributed by:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue, Wayne, PA. 19087 USA
www.emersongroup.com
* Please review the disclaimer below.
