ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH- neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride cream 
Consumer Value Stores

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.

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Consumer Value Stores

Antibiotic and Pain Relief (Maximum Strength)

Active Ingredients (in each gram)

Neomycin 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine Hydrochloride 10 mg

Purposes

First aid and antibiotic and pain reliever


Uses

Helps prevent infection in and temporarily relieves pain due to

  • minor cuts
  • scrapes
  • burns

Allergy alert:

  • do not use if allergic to any of the ingredients

Warnings

For external use only.

Do not use

  • in or near the eyes
  • on large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

do not use longer than 1 week

Stop use and ask a doctor if

  • condition lasts or gets worse
  • a rash or other allergic reaction occurs
  • symptoms last for more than 7 days or clear up and come back 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 and older:

  • clean affected area
  • may be covered with a sterile bandage
  • apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily

Children under 2 years: ask a doctor.

Other information

store at 59o-86oF (15o-30oC)

Inactive Ingredients

cetanol, liquid parafin, methylparaben, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid


Questions?

Call toll-free 1-800-645-3867

Image of Antibiotic and Pain Relief Cream 1 oz Carton Label

Image of Antibiotic and Pain Relief Cream 1 oz Tube Label


ANTIBIOTIC AND PAIN RELIEF  MAXIMUM STRENGTH
neomycin sulfate, polymyxin b sulfate, pramoxine hci cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-822
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Neomycin Sulfate (Neomycin) Neomycin Sulfate3.5 mg  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate10000 [iU]  in 1 g
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Cetyl Alcohol 
Petrolatum 
Propylene Glycol 
Stearic Acid 
Mineral Oil 
Polysorbate 60 
Sorbitan Monostearate 
Methylparaben 
Propylparaben 
Water 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-822-341 in 1 CARTON
114 g in 1 TUBE
2NDC:59779-822-561 in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/01/2011
Labeler - Consumer Value Stores (062312574)

Revised: 11/2010
 
Consumer Value Stores