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Drug Facts
Astonea Extra Strength Anti-itch Cream
FDA Label NDC 77338-215
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 Extra Strength Anti-itch Cream (NDC 77338-215). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Diphenhydramine hydrochloride 2% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
Uses
- temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- minor skin irritations
- rashes due to poison ivy, poison oak, oak, and sumac
- dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Warnings
For external use only
Otc - Do Not Use
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
Otc - Ask Doctor
Ask a doctor before use
- on chicken pox
- on measles
Otc - When Using
When using this product
- use only as directed
- avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a physician
Other Information
- store at 20°C-25°C (68°C/77°F)
- do not use if tube seal under cap is broken
Inactive Ingredients
Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Edetate disodium, Light Mineral Oil, Petrolatum, Propylene Glycol, Sodium metabisulsulfite, Water
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