ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH- neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream
Rite Aid

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.

----------

first aid antibiotic plus pain relief cream maximum strength - Rite Aid

Drug Facts

Active ingredients (in each gram)

Neomycin 3.5 mg
Polymyxin B sulfate, USP 10,000 units
Pramoxine hydrochloride, USP 10 mg

Purposes

First aid antibiotic/Pain reliever

Uses

First aid to help prevent infection in and for temporary relief of pain or discomfort due to:
•minor cuts •scrapes •burns

Warnings

For external use only

Allergy alert:

•do not use if allergic to any of the ingredients

Do not use

•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

When using this product

•do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

•condition persists or gets worse
•symptoms last for more than 7 days or clear up and occur again within a few days
•a rash or other allergic reaction occurs

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 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 59º-86ºF (15º-30ºC)
•Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

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

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY
NDC 11822-8220-2
*Compare to the active ingredients
in Neosporin® + Pain Relief

MAXIMUM STRENGTH
first aid
antibiotic + pain relief cream

neomycin sulfate • polymmyxin B sulfate • pramoxine HCI

first aid antibiotic/pain relieving cream
helps prevent infection and for temporary relief
of pain due to minor cuts, scrapes and burns

NET WT 1 OZ (28 g)

ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH
neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-8220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLOXAMER 188 (UNII: LQA7B6G8JG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-8220-2	1 in 1 CARTON	10/02/2006	02/28/2018
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part347	10/02/2006	03/07/2018

Labeler - Rite Aid (014578892)

Revised: 12/2017

Document Id: 90c3b346-add8-4e8d-9d74-9208379081c5

Set id: 25ccac09-51f9-491e-9a7e-2aaea5872add

Version: 4

Effective Time: 20171204

Rite Aid