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Family wellness by FRONT PHARMACEUTICAL PLC

Dosage form: ointment
Ingredients: BACITRACIN ZINC .41g in 100g, NEOMYCIN SULFATE .0035g in 100g, POLYMYXIN B SULFATE .52g in 100g
Labeler: FRONT PHARMACEUTICAL PLC
NDC Code: 69571-003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses  first aid to help prevent infection in minor:

-uses     -scrapes   -burns

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients in this product
  • in contact with the eyes or mucous membranes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • symptoms persist for mroe than 7 days, the condition persists or gets worse
  • symptoms clear up and then occur again within a few days
  • a rash or other allergic reaction occurs

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product to affected area 1 to 3 times daily
  • May be covered with a sterile bandage.

Children under 2 years of age: ask a doctor before use.

Other information  store at room temperature 68 - 77 F

(20-25 C).

Questions?  1-800-639-3803  Weekdays 9 AM to 4 PM EST

Inactive ingredients  mineral oil, petrolatum

FAMILY WELLNESS 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN.41 g  in 100 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN.0035 g  in 100 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B.52 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:69571-003-021 TUBE in 1 BOX
1NDC:69571-003-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/22/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIOperations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-003)

Revised: 02/2017
 
FRONT PHARMACEUTICAL PLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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