Active Ingredients:
Aluminium Hydroxide Gel 2 % w/w
Astoneagran
FDA Label NDC 77338-021
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 Astoneagran (NDC 77338-021). 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:, purpose, uses:, warnings:, otc - do not use, 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
Purpose
Skin Protectant
Uses:
- Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac, or other skin irritations
Warnings:
For external use only.
Otc - Do Not Use
■Deep or puncture wounds ■Animal bites ■Serious burns
Avoid contact with eyes. In case of contact, flush thoroughly with water
Stop Use And Ask A Doctor If
■Condition worsens
■Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
In case of accidental ingestion contact a physician or Poison Control Center right away
Directions
Apply liberally to affected area as needed or as directed by a physician ■Children under 6 months: ask a doctor
Other Information
■Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredient
Calcium Carbonate, Cholecalciferol, Citric Acid, DMDM Hydantoin, Ethylhexylglycerin, Lanolin, Lanolin Alcohol, Magnesium Hydroxide, Petrolatum, Phenoxyethanol, Propylene Glycol, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Zea Mays Corn Oil, Zinc Chloride
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Principal Display And Drug Fact Panel (Astonea)
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