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NDC 36800-0416-58 topcare triple antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

topcare triple antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g

topcare triple antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

MedlinePlus Drug Summary

Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.

Related Packages: 36800-0416-58
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	36800-0416
Product ID	36800-416_6a961ec1-d3e2-4d75-9473-7303f17f58cc
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 triple antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	bacitracin zinc, neomycin, polymyxin B
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; 3.5; 5000
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], 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 36800-0416-58 (36800041658)

Pricing Information	N/A
NDC Package Code	36800-416-58
Billing NDC	36800041658
Package	1 TUBE in 1 CARTON (36800-416-58) / 14.2 g in 1 TUBE
Marketing Start Date	2020-02-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 675665ee-bd0d-4168-81b8-341b1258c102 Details

Active ingredients (in each gram)

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Purpose

First aid antibiotic

Use

first aid to help prevent infection in minor:

•: cuts
•: scrapes
•: burns

Warnings

For external use only.

Do not use

•: if you are allergic to any of the ingredients
•: 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

Stop use and ask a doctor if

•: you need to use longer than 1 week
•: condition persists or gets worse
•: 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. (1-800-222-1222)

Directions

•: 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
•: may be covered with a sterile bandage

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO NEOSPORIN® ACTIVE INGREDIENTS

First Aid Antibiotic Ointment

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

Original Strength

ORIGINAL STRENGTH

OUR PHARMACISTS RECOMMEND

Triple Antibiotic Ointment

BACITRACIN ZINC, NEOMYCIN SULFATE & POLYMYXIN B SULFATE

First Aid Antibiotic Ointment

NET WT 0.5 OZ (14.2 g)

INGREDIENTS AND APPEARANCE

TOPCARE TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-416
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U] in 1 g
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	5000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-416-58	1 in 1 CARTON	02/26/2020
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:36800-416-64	1 in 1 CARTON	02/26/2020
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:36800-416-26	2 in 1 CARTON	02/26/2020
3		56 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	02/26/2020

Labeler - Topco Associates LLC (006935977)

Revised: 4/2021

Document Id: 6a961ec1-d3e2-4d75-9473-7303f17f58cc

Set id: 675665ee-bd0d-4168-81b8-341b1258c102

Version: 3

Effective Time: 20210402