Active Ingredients
Corn Starch 79%
Kaolin 4%
Zinc Oxide 15%
Medicated Cornstarch Baby Powder
FDA Label NDC 42669-231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Davion, Inc. for the product Medicated Cornstarch Baby Powder (NDC 42669-231). 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 ingredients, purposes, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Skin Protectant
Uses
- Prevents chafed skin and reduces minor skin irritations due to diaper rash
- Helps protect from wetness
Warnings
For external use only.
When Using This Product
- Avoid contact with eyes
- Do not use on broken skin
- Keep powder away from child's face to avoid inhalation which can cause breathing problems
Stop Use And Ask A Doctor If
- If conditions worsen or symptoms do not get better within 7 days
Keep Out Of Reach Of Children.
If ingested, get medical help or contact a Poison Control Center immediately.
Directions
Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged. Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to diaper area.
Adults and children 2 years and older: apply freely up to 3 or 4 times daily. For best results, dry skin thoroughly before applying.
Inactive Ingredients
Fragrance, Silica
* Please review the disclaimer below.
