Drug Facts

Active ingredients (in each gram)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Uses

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

cuts
scrapes
burns

Warnings

For external use only.

Not for prolonged use.

Do Not Use

in the eyes, nose, or over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
a rash or other allergic reaction develops
redness, irritation, swelling, or pain persists or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults and children 2 years of age and 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
the affected area may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Other information

store at 15 to 30°C (59 to 86°F)
contents filled by weight, not volume
Tamper Evident: DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING

Inactive ingredients

cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

Questions or comments?

866-323-0107

Distributed by
Geiss, Destin & Dunn, Inc
Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

GOODSENSE®
NDC 50804-076-01

Maximum Strength

Antibiotic Cream + Pain Relief
Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl
First Aid Antibiotic Pain Relieving Cream

Compare to active ingredients in
Neosporin® + Pain Relief*

100%
SATISFACTION
GUARANTEED

NET WT 0.5 oz (14.2 g)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

GOODSENSE ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-076
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 [iU] 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)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-076-01	1 in 1 CARTON	03/21/2012
1		14.2 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 FINAL	part333B	03/21/2012

Labeler - Geiss, Destin & Dunn, Inc. (076059836)

Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(50804-076)

GoodSense® Antibiotic Cream + Pain Relief