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NDC 50804-0076-01 GoodSense 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details

GoodSense 3.5; 10000; 10 mg/g; [iU]/g; mg/g

GoodSense is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Geiss, Destin & Dunn, Inc.. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	50804-0076
Product ID	50804-076_19775c31-e4d6-4e77-958c-02d9cae34fb9
Associated GPIs	90109803353720
GCN Sequence Number	052110
GCN Sequence Number Description	neomycin/polymyxin B/pramoxine CREAM (G) 3.5-10K-10 TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	19626
HICL Sequence Number	025197
HICL Sequence Number Description	NEOMYCIN SULFATE/POLYMYXIN B SULFATE/PRAMOXINE
Brand/Generic	Generic
Proprietary Name	GoodSense
Proprietary Name Suffix	Antibiotic plus Pain Relief
Non-Proprietary Name	Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	3.5; 10000; 10
Active Ingredient Units	mg/g; [iU]/g; mg/g
Substance Name	NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	Geiss, Destin & Dunn, Inc.
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0076-01 (50804007601)

Pricing Information	N/A
NDC Package Code	50804-076-01
Billing NDC	50804007601
Package	1 TUBE in 1 CARTON (50804-076-01) / 14.2 g in 1 TUBE
Marketing Start Date	2012-03-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d79ece7-6b24-4aac-a8a3-e6cdcd605d27 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

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

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)

Revised: 1/2020

Document Id: 19775c31-e4d6-4e77-958c-02d9cae34fb9

Set id: 3d79ece7-6b24-4aac-a8a3-e6cdcd605d27

Version: 2

Effective Time: 20200124

Search by Drug Name or NDC

NDC 50804-0076-01 GoodSense 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details

GoodSense 3.5; 10000; 10 mg/g; [iU]/g; mg/g

Product Information

Package

Package Images

NDC 50804-0076-01 (50804007601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3d79ece7-6b24-4aac-a8a3-e6cdcd605d27 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do Not Use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

INGREDIENTS AND APPEARANCE

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