Active Ingredient
Zinc Oxide 10%
Diaper Rash
FDA Label NDC 67510-0502
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Diaper Rash (NDC 67510-0502). 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, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., 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
- helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips
Warnings
For external use only
Do Not Use
over deep or puncture wounds, infections or lacerations
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor
if condition worsens or does not improve within 7 days.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
- store at room temperature
- Lot No and Exp Date: see box or see crimp of tube
Inactive Ingredients
Talc, Vacillin, Bees wax, Demethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water
Package Label
Diaper Rash Cream
Image Of Product Carton (Diaperrash.carton)
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