Active Ingredient
Bacitracin zinc 500 Units
Neomycin sulfate (3.5mg)
Polymyxin B sulfate (10000 units)
Pramoxine HCI (10mg)
Astoneatriple Antibiotic Pain Relief
FDA Label NDC 77338-229
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 Astoneatriple Antibiotic Pain Relief (NDC 77338-229). 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, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
external analgesic
Uses
First Aid to help prevent infection and for temporary relief of pain in minor:
- Cuts
- Scrapes
- Burns
Warnings
For external use only.
Do Not Use
If you are allergic to any of the ingredients
In eyes
Over large areas of the body
Ask A Doctor Before Use
Ask Doctor before use if you have:
- Deep or puncture wouns
- Animal bites
- Serious burns
When Using This Product
use only as directed
Stop Use And Ask A Doctor If:
- You need to use longer than 1 week
- Condition persists or gets worse
- rash or other allergic reaction develops
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 or children 2 years of age and older:
- Clean the affected area
- Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- May be covered with a sterile bandage
- Children under 2 years of age: ask doctor
Other Information
- Store at 20° to 25°C (68° to 77°F)
- do not use if tube seal under cap is broken
Inactive Ingredient:
White Petrolatum
* Please review the disclaimer below.
