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NDC 36800-0780-64 topcare triple antibiotic 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

topcare triple antibiotic 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/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; PRAMOXINE HYDROCHLORIDE.

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: 36800-0780-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 36800-0780-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	36800-0780
Product ID	36800-780_6173dcac-e635-4ae3-a911-bff0605d636e
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, pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 3.5; 10000; 10
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/g; mg/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
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 36800-0780-64 (36800078064)

Pricing Information	N/A
NDC Package Code	36800-780-64
Billing NDC	36800078064
Package	1 TUBE in 1 CARTON (36800-780-64) / 28 g in 1 TUBE
Marketing Start Date	2020-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5e0fc39b-e6d4-4543-8afc-2881e2f85f9b Details

Active ingredients (in each gram)

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort 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
•: 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. (1-800-222-1222)

Directions

•: adults and children 2 years of age or 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
•: may be covered with a sterile bandage
•: children under 2 years of age: ask a doctor

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredient

white petrolatum

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO NEOSPORIN® + PAIN RELIEF

ACTIVE INGREDIENTS

First Aid Antibiotic & Pain Relieving Ointment

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength

TopCare® health

MAXIMUM STRENGTH

Triple Antibiotic Ointment + Pain Relief

BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

TOPCARE TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin, polymyxin b, pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-780
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [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	10000 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-780-64	1 in 1 CARTON	03/15/2020
1		28 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	03/15/2020

Labeler - Topco Associates LLC (006935977)

Revised: 2/2022

Document Id: 6173dcac-e635-4ae3-a911-bff0605d636e

Set id: 5e0fc39b-e6d4-4543-8afc-2881e2f85f9b

Version: 3

Effective Time: 20220228