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Name:Antibiotic
Manufacturer:Rite Aid Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Rite Aid Corporation Antibiotic Cream Drug Facts

ANTIBIOTIC - neomycin sulfate, pramoxine hydrochloride and polymyxin b sulfate cream 
Rite Aid Corporation

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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Rite Aid Corporation Antibiotic Cream Drug Facts

Active ingredient (in each gram)

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • 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 or older
  • clean the affected area
  • 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°-25°C (68°-77°F)

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Soothing Cream

Compare to the active ingredients in Neosporin®

1. Polymyxin B Sulfate

2. Neomycin PLUS Pramoxine

Maximum Strength Cream

Antibiotic Cream

Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine HCl

First Aid Antibiotic/Pain Relieving Cream

Plus!

Pain Relieving

Pramoxine HCl

Antibiotic Cream Carton

Antibiotic Cream Carton


ANTIBIOTIC 
neomycin, polymyxin b, pramoxine hcl cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0809
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
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP'U]  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0809-1 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 14 g in 1 TUBE This package is contained within the CARTON (11822-0809-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 08/04/2005

Labeler - Rite Aid Corporation (014578892)

Revised: 07/2009 Rite Aid Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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