Otc - Active Ingredient
Active ingredients (in each gram)
Bacitracin zinc, USP 500 units
Family Wellness Ointment
FDA Label NDC 69571-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Family Wellness (NDC 69571-008). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
First aid antibiotic
Indications & Usage
Uses
first aid to help prevent infection in
•minor cuts •scrapes •burns
Warnings
Warnings For external use only
Allergy alert
•do not use if allergic to any of the ingredients
Do not use
•in or near eyes
•on large areas of the body
Ask a doctor before use if you have
•deep or puncture wounds
•animal bites •serious burns
When using this product
•do not use longer than 1 week
Stop use and ask a doctor if
•condtions last or gets worse
•symptoms last for more than 7 days or clear up and
come back within a few days
•if rash or other allergic reaction occurs
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.
Dosage & Administration
Directions
•adults and children 2 years of age and older:
•clean affected area
•apply a small amount (equal to surface area of tip of
finger) on area 1 to 3 times dailt
•may be covered by a sterile bandage
•children under 2 years of age:
•ask a doctor
Other Safety Information
Other Information
•Store at room temperature 54° - 77° (15° - 25° C)
•Before using any medication, read all label direcitons.
Keep carton. It contains important information
Inactive Ingredient
Inactive ingredients mineral oil, white petrolatum
Otc - Questions
Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST
Package Label.Principal Display Panel
Image Description (Front Baci)
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