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Shopko Antibiotic Plus Pain Relief

Dosage form: cream
Ingredients: Neomycin Sulfate 3.5mg in 1g, Polymyxin B Sulfate 10000[iU] in 1g, Pramoxine Hydrochloride 10mg in 1g
Labeler: Shopko Stores Operating Co., LLC
NDC Code: 37012-506

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.

Shopko®
Antibiotic Cream Plus Pain Relief

Drug Facts

Active ingredients (each gram contains)Purpose
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10 mgExternal 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
  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • 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 and dry thoroughly
  • 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: ask a doctor

Other information
  • store at 20° to 25°C (68° to 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 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

SHOPKO®
NDC 37012-506-01

Maximum Strength

Antibiotic Cream + Pain Relief

Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Cream

NET WT ½ OZ (14.2 g)

SHOPKO   ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-506
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Neomycin Sulfate (Neomycin) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B10000 [iU]  in 1 g
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
methylparaben 
mineral oil 
propylene glycol 
water 
petrolatum 
Packaging
#Item CodePackage Description
1NDC:37012-506-011 TUBE in 1 CARTON
114.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B03/21/2012
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(37012-506)

Revised: 04/2014
 
Shopko Stores Operating Co., LLC

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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