Active Ingredient
Zinc Oxide, 40%
Maximum Strength Diaper Rash
FDA Label NDC 59779-849
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Maximum Strength Diaper Rash (NDC 59779-849). 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, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions for use, 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 seal out wetness
Warnings
For external use only.
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
condition worsens or does not improve after 7 days
Keep Out Of Reach Of Children
to prevent accidential ingestion. If swallowed, seek medical help or call Poison Control Center immediately.
Directions For Use
change wet and soiled diaper immediately, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary with each diaper change and especially when exposured to wet diapers for a prolonged period of time, such as bedtime
Other Information
Storage temperature: not to exceed 30oC (86oF),
Remove foil seal from the tube's tip,
Use with infants, children, and adults,
Will stain clothing and fabric
Inactive Ingredients
Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum
* Please review the disclaimer below.
