Drug Facts Active Ingredients
Menthol 0.15 %
Zinc Oxide 1.0%
Astonea Medicated Body Powder
FDA Label NDC 77338-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Astonea Medicated Body Powder (NDC 77338-403). 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 drug facts active ingredients, purpose, uses, keep out of reach of children, warnings, when usin this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Skin Protectant
Uses
for the temporary relief of the pain and itch associated with
- minor cuts
- scrapes
- sunburn
- insect bites
- prickly heat
- rashes
- minor burns
- minor skin irritations
- dries the oozing of poison ivy, oak and sumac.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidential ingestion, get medical help or contact a Poison Control Center right away.
Warnings
For external use only
When Usin This Product
- Avoid contact with eyes.
- Keep away from face and mouth to avoid inhalation
- Not for genital area.
Stop Use And Ask A Doctor If
- condition worsens
- symptoms do not get better within 7 days or clear up and occur again within a few days
Directions
- adults and children 2 years and older, apply freely up to 3 or 4 times daily
- under 2 years: ask a doctor before using
- for best results, dry skin thoroughly before use
Inactive Ingredients
Corn Starch, Eucalyptol, Gum Talha, Methyl Salicylate, Salicylic Acid, Sodium Bicarbonate, Thymol, Tricalcium Phosphate, Zinc Stearate
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