First Aid Antiseptic Ointment
FDA Label NDC 0536-1271
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product First Aid Antiseptic (NDC 0536-1271). 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 ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, 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
Active Ingredient
Povidone Iodine USP 10% w/w (available iodine 1%)
Purpose
First aid antiseptic
Uses
first aid to help prevent infection in minor:
- cuts
- scrapes
- burns
Warnings
For external use only.
Do Not Use
- if you are allergic to any of the ingredients
- over large areas of the body
- longer than 1 week unless directed by a doctor
- in the eyes
Ask A Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
Stop Use And Ask A Doctor If
condition persists or gets worse
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- clean the affected area
- apply a small amount of this product on the area 1 to 3 times daily
- may be covered with a sterile bandage
Other Information
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- close cap tightly after use
Inactive Ingredients
mineral oil, petrolatum
Questions Or Comments?
1 (800) 645-2158
Package Labeling:
* Please review the disclaimer below.