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Double Antibiotic by Rebel Distributors Corp

Dosage form: ointment
Ingredients: Bacitracin Zinc 500[USP'U] in 1g, Polymyxin B Sulfate 1000[USP'U] in 1g
Labeler: Rebel Distributors Corp
NDC Code: 21695-400

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.

Fougera ® Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Uses first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burn

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Ask a doctor before use in case of deep or puncture wounds, animal bites or serious bums

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a 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.

Directions

  • 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

Other information

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
  • see crimp of tube for Lot No. and Exp. date

Inactive ingredient white petrolatum

Questions or comments ? call toll free 1-800-645-9833

Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

DOUBLE ANTIBIOTIC 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-400(NDC:0168-0021)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin Zinc500 [USP'U]  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate1000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:21695-400-301 TUBE (TUBE) in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/06/2010
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Medically reviewed on Feb 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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