ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH- 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 + Pain Relief Cream Drug Facts

Active ingredient (in each gram)

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

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. (1-800-222-1222)

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 20o-25oC (68o-77oF)

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

Compare to the active ingredients of Neosporin® + Pain Relief

MAXIUMUM STRENGTH

first aid

antibiotic + pain relief cream

neomycin sulfate – polymyxin B sulfate – pramoxine HCl

first aid antibiotic/pain relieving cream

helps prevent infection and for temporary relief of pain due to minor cuts, scrapes and burns

Antibiotic Plus Pain Relief Cream Carton Image 2
ANTIBIOTIC PLUS PAIN RELIEF  MAXIMUM STRENGTH
neomycin, polymyxin b, pramoxine hcl cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-0637
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
MINERAL OIL 
POLOXAMER 188 
PROPYLENE GLYCOL 
WATER 
PETROLATUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0637-11 in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/14/2005
Labeler - Rite Aid Corporation (014578892)

Revised: 5/2013
Document Id: b1b32f48-91e5-4c94-bbf5-091b8d177ef5
Set id: b1b32f48-91e5-4c94-bbf5-091b8d177ef5
Version: 1
Effective Time: 20130526
 
Rite Aid Corporation