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NDC 36800-0381-01 TopCare 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details

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

TopCare is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	36800-0381
Product ID	36800-381_1fad778c-f98c-4ce4-8450-3e02f54fb3a6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TopCare
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	Topco Associates LLC
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 36800-0381-01 (36800038101)

Pricing Information	N/A
NDC Package Code	36800-381-01
Billing NDC	36800038101
Package	1 TUBE in 1 CARTON (36800-381-01) / 14.2 g in 1 TUBE
Marketing Start Date	2012-03-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 55dc4025-f07f-41b2-8b18-6a11ee04b5cc Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (each gram contains)	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 for the temporary relief of pain or discomfort in minor:

cuts
scrapes
burns

Warnings

For external use only.

Do not use

in the eyes
over large areas of the body
if you are allergic to any of the ingredients

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 or gets worse
you need to use longer than 1 week
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.

Directions

Adults and children 2 years of age and older:

clean the affected area and dry thoroughly
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 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

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

Questions?

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE,

IL 60007

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

NDC 36800-381-01

TopCare®

health™

MAXIMUM STRENGTH

Antibiotic Cream + Pain Relief

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCL

• OUR PHARMACISTS

RECOMMEND •

NET WT 0.5 OZ (14.2 g)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

INGREDIENTS AND APPEARANCE

TOPCARE ANTIBIOTIC PLUS PAIN RELIEF

neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-381
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:36800-381-01	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 - Topco Associates LLC (006935977)

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

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(36800-381)

Revised: 3/2019

Document Id: 1fad778c-f98c-4ce4-8450-3e02f54fb3a6

Set id: 55dc4025-f07f-41b2-8b18-6a11ee04b5cc

Version: 2

Effective Time: 20190308

Search by Drug Name or NDC

NDC 36800-0381-01 TopCare 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details

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

Product Information

Package

Package Images

NDC 36800-0381-01 (36800038101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 55dc4025-f07f-41b2-8b18-6a11ee04b5cc 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?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

INGREDIENTS AND APPEARANCE

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