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NDC 71101-0210-01 TheraCare First Aid Triple Antibiotic 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g Details

TheraCare First Aid Triple Antibiotic 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g

TheraCare First Aid Triple Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. 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: 71101-0210-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	71101-0210
Product ID	71101-210_c1609455-76a8-a5ac-e053-2995a90ac405
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	TheraCare First Aid Triple Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; 3.5; 5000
Active Ingredient Units	[iU]/g; mg/g; [iU]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	Veridian Healthcare
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 71101-0210-01 (71101021001)

Pricing Information	N/A
NDC Package Code	71101-210-01
Billing NDC	71101021001
Package	1 TUBE in 1 CARTON (71101-210-01) / 28.3 g in 1 TUBE
Marketing Start Date	2021-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c16093e0-6002-6ba0-e053-2995a90a06a3 Details

Active Ingredients

Bacitracin zinc
Neomycin sulfate
Polymyxin B Sulfate

Active ingredients (in each gram)	Purpose
Bacitracin 400 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 5,000 units	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

When Using this product

use only as directed

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° to 25°C (68° to 77° F)
do not use if tube seal under cap is broken

Inactive ingredients

alpha-tocopherol acetate, cocoa butter, cottonseed oil, light mineral oil, olive oil, paraffin, petrolatum, sodium pyruvate

TheraCare First Aid Triple Antibiotic Ointment

INGREDIENTS AND APPEARANCE

THERACARE FIRST AID TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-210
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
COCOA BUTTER (UNII: 512OYT1CRR)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-210-01	1 in 1 CARTON	04/01/2021
1		28.3 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	04/01/2021

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-210)

Revised: 5/2021

Document Id: c1609455-76a8-a5ac-e053-2995a90ac405

Set id: c16093e0-6002-6ba0-e053-2995a90a06a3

Version: 1

Effective Time: 20210502