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

GoodSense by

Drug Labeling and Warnings

GoodSense by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc., Taro Pharmaceuticals U.S. A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	03/21/2012

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

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

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