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NDC 72976-0009-01 Ever Ready First Aid Triple Antibiotic 400; .0035; 5000 [USP'U]/g; g/g; [USP'U]/g Details

Ever Ready First Aid Triple Antibiotic 400; .0035; 5000 [USP'U]/g; g/g; [USP'U]/g

Ever Ready First Aid Triple Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by EVER READY FIRST AID. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

Product Information

NDC	72976-0009
Product ID	72976-009_ee1ad6d7-e9c2-2b20-e053-2995a90a3366
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	Ever Ready First Aid Triple Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; .0035; 5000
Active Ingredient Units	[USP'U]/g; g/g; [USP'U]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	EVER READY FIRST AID
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	2023-12-31

Package

Package Images

NDC 72976-0009-01 (72976000901)

Pricing Information	N/A
NDC Package Code	72976-009-01
Billing NDC	72976000901
Package	.9 g in 1 POUCH (72976-009-01)
Marketing Start Date	2022-11-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ee1ad6d7-e9c1-2b20-e053-2995a90a3366 Details

Active ingredients

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B sulfate First aid

(Polymyxin B 5000 units)

Purpose

antibiotic

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do not use

internally
in eyes
over large areas of the body or on puncture wounds, animal bites or serious burns
for more then 1 week unless directed by a doctor
if you are allergic to any of the ingredients

Stop use and ask a doctor if

a rash or allergic reaction develops
condition worsens or persists

Keep out of reach of children

If ingested, contact a Poison Control Center right away.

Directions

clean affected area
apply a small amount 1 to 3 times daily
may cover with a sterile bandag

Inactive ingredients

Mineral oil, Petroleum, Purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVER READY FIRST AID TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72976-009
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	0.0035 g 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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72976-009-01	0.9 g in 1 POUCH; Type 0: Not a Combination Product	11/23/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	11/23/2022

Labeler - EVER READY FIRST AID (147372960)

Revised: 11/2022

Document Id: ee1ad6d7-e9c2-2b20-e053-2995a90a3366

Set id: ee1ad6d7-e9c1-2b20-e053-2995a90a3366

Version: 1

Effective Time: 20221122