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.

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Safeway
Antibiotic Plus Pain Relief

Drug Facts

Active ingredients (each gram contains)Purpose
Neomycin sulfate 3.5mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10mgTopical analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain or discomfort in

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:

Children under 2 years of age: Consult a doctor.

Other information

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
SAFEWAY   ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [iU]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-076-011 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 - Safeway Inc (009137209)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(21130-076)

Revised: 3/2013
Document Id: 73ba9788-7b61-444d-aee1-67b896dc3c57
Set id: 9ce7bb16-d30c-4b32-ba19-48edda8ebc9b
Version: 1
Effective Time: 20130306
 
Safeway Inc