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Safeway

SAFEWAY INC
Taro Pharmaceuticals U.S.A., Inc.

Safeway Antibiotic Plus Pain Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Safeway 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
  • longer than 1 week

Ask a doctor before use

  • on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • condition 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 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: Consult a doctor.

Safeway Other information

  • store at controlled room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

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

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99
PLEASANTON, CA 94566-0009

1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL - 14.2g Tube Carton

Maximum Strength

NDC 21130-076-01

Antibiotic Cream + Pain Relief

• Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

NET WT ½ OZ (14.2g)

SAFEWAY

Safeway

Safeway

Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-076
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Neomycin Sulfate NEOMYCIN 3.5 mg
Polymyxin B Sulfate POLYMYXIN B 10000 [iU]
pramoxine hydrochloride PRAMOXINE 10 mg

Inactive Ingredients

Ingredient Name Strength
METHYLPARABEN
Mineral Oil
propylene glycol
water
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 14.2 in 1 TUBE
2 NDC:21130-076-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part333B 2012-03-21


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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