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Triple Antibiotic Plus

Dosage form: ointment
Ingredients: Polymyxin B Sulfate 10000[USP'U] in 1g, Bacitracin Zinc 500[USP'U] in 1g, Neomycin 3.5mg in 1g, Pramoxine Hydrochloride 10mg in 1g
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0622

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.

Triple Antibiotic Plus Ointment
Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl

ACTIVE INGREDIENT (in each gram)

Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units
Pramoxine hydrochloride 10.0 mg

PURPOSE

First Aid Antibiotic
Topical analgesic

USES

first aid to help prevent infection and provide temporary relief of pain or discomfort in minor • cuts • scrapes • burns

WARNINGS

For external use only.
Do not use
• if you are allergic to any of the ingredients
• in the eyes
 • over large areas of the body
• longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if
• the condition persists or gets worse
• a rash or other allergic reaction develops
• symptoms persist for more than 1 week, or clear up and occur again within a few days

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 (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
• children under 2 years of age: consult a doctor

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENT

light mineral oil, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G&W
Triple Antibiotic Plus Ointment
Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl
First Aid Antibiotic / Pain Relieving Ointment
NET WT. 1 oz (28.4g)

TRIPLE ANTIBIOTIC PLUS  
polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0622
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate10000 [USP'U]  in 1 g
Bacitracin Zinc (Bacitracin) Bacitracin Zinc500 [USP'U]  in 1 g
Neomycin (Neomycin) Neomycin3.5 mg  in 1 g
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Light Mineral Oil 
Petrolatum 
Packaging
#Item CodePackage Description
1NDC:0713-0622-3128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/28/1998
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 01/2012
 
G&W Laboratories, Inc.

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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