Active Ingredient
Active ingredient
Zinc Oxide 16%
The following Structured Product Label (SPL) was submitted to the FDA by American Consumer Products Corp for the product Babys Butt Aid (NDC 72197-039). 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, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Zinc Oxide 16%
Purpose
Skin Protectant
Uses • Helps treat and prevent diaper rash • Prevents chafed skin due to diaper rash and helps seal out wetness.
Warnings
For external use only.
When using this product, avoid contact with 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 any time when exposure to wet diapers may be prolonged.
Other information: store at 20° to 27°C (68° to 80.6°F)
Inactive ingredients: boric acid, castor oil, fragrance, microcrystalline wax, mineral oil, paraffin, petrolatum.
Distributed By: American Consumer Products Corp
Vernon, CA 90058
MADE IN CHINA
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