Antibiotic Plus Pain Relief

Generic Name: neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride
Dosage Form: cream

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.

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:

Slideshow: Fact or Fiction? The Top 15 Osteoarthritis Myths

  • 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 Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:52426-220-05 1 TUBE (TUBE) in 1 CARTON
1 14.2 g in 1 TUBE
2 NDC:52426-220-06 1 TUBE (TUBE) in 1 CARTON
2 28.4 g in 1 TUBE
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: 09/2010
 
Phoenix Global Supply Group, Inc.



More about Antibiotic Plus Pain Relief (neomycin / polymyxin b / pramoxine topical)

Hide
(web3)