Antibiotic Plus Pain Relief

neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride

Dosage Form: cream
Antibiotic

Cream + Pain Relief

Drug Facts

Active ingredients (each gram contains)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	External analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

• cuts


• scrapes


• burns

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 if you have

• deep or puncture wounds


• animal bites


• serious burns

Stop use and ask a doctor if

• condition persists or gets worse


• condition persists for more than 7 days


• condition clears up and occurs again within a few days


• 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

• 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

• To open: unscrew cap, pull tab to remove foil seal.


• store at 20°-25°C (68°-77°F)


• See carton or tube crimp for lot number and expiration date.

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

Questions?

Call 1-877-745-6888

Distributed by:

Phoenix Global Supply Group, Inc.

White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Antibiotic

Cream + Pain Relief

Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Cream

Maximum Strength

NET WT 1 oz (28.4 g)

Antibiotic Plus Pain Relief  neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride  cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 52426-220 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Neomycin Sulfate (Neomycin) Neomycin Sulfate 3.5 mg  in 1 g Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate 10000 [iU]  in 1 g Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength methylparaben   mineral oil   propylene glycol   water   petrolatum

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52426-220-05 1 TUBE In 1 CARTON contains a TUBE 1 14.2 g In 1 TUBE This package is contained within the CARTON (52426-220-05) 2 52426-220-06 1 TUBE In 1 CARTON contains a TUBE 2 28.4 g In 1 TUBE This package is contained within the CARTON (52426-220-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	09/23/2010

Labeler - Phoenix Global Supply Group, Inc. (843189908)

Establishment
Name	Address	ID/FEI	Operations
SGS Life Science Services		093840643	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Axellia Pharmaceuticals ApS		305814345	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pharmacia and UpJohn Company		829076566	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Syn-Tech Chem. & Pharm. Co., Ltd.		656002532	API MANUFACTURE

Revised: 09/2010Phoenix Global Supply Group, Inc.

More Antibiotic Plus Pain Relief resources

• Antibiotic Plus Pain Relief Use in Pregnancy & Breastfeeding
• Antibiotic Plus Pain Relief Drug Interactions
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