Otc - Active Ingredient
Active ingredient (in each gram) Purpose
Bacitracin Zinc 500 units..............................................First aid antibiotic
Family Care First Aid Ointment
FDA Label NDC 65923-491
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care First Aid (NDC 65923-491). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- first aid to help prevent infection in minor:
- cuts
- scrapes
- burns
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
Otc - Ask Doctor
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- clean the affected area
- apply a small amount of this product (an amount 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
Storage And Handling
Other information
store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum stearyl alcohol
Dosage & Administration
Distributed by: United Exchange Corp.
Cypress, CA 90630 USA
Made in China
Package Label.Principal Display Panel
496a (496a)
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