OTC Medication Information: Safeway Antibiotic Plus Pain Relief

SAFEWAY ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride cream
Safeway Inc

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.

Drug Facts

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

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.

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

PRINCIPAL DISPLAY PANEL -- 14.2 g Tube Carton
(click image for full-size original)
SAFEWAY ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG 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) Neomycin 3.5 mg in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B 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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21130-076-01 1 TUBE in 1 CARTON contains a TUBE
1 14.2 g in 1 TUBE This package is contained within the CARTON (21130-076-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 03/21/2012
Labeler — Safeway Inc (009137209)
Registrant — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE (21130-076)

Revised: 03/2013 Safeway Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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