ULTRA SEAL TRIPLE ANTIBIOTIC- neomycin, polymixin, bacitracin ointment
Ultra Seal Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ULTRA SEAL Triple Antibiotic

Actve Ingredients: In each gram-Neomycin Sulfate-5 mg (equivalent to 3.5 mg Neomycin), Polymixin B Sulfate-5000 I.U., Bacitracin Zinc-400 I.U.

PURPOSE: FIRST AID ANTIBIOTIC

FIRST AID TO HELP PREVENT INFECTION IN MINOR CUTS, BURNS, SCRAPES

FOR EXTERNAL USE ONLY. DO NOT USE IN THE EYES. DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS DUE TO THE POSSIBILITY OF ANAPHYLACTIC SHOCK.

STOP USE AND ASK A DOCTOR BEFORE USE IN CASES OF DEEP PUNCTURE WOUNDS, ANIMAL BITES, SERIOUS BURNS; IF THE CONDITION PERSISTS OR GETS WORSE;IF A RASH OR OTHER ALLERGIC REACTION DEVELOPS

IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

KEEP OUT OF THE REACH OF CHILDREN

CLEAN THE AFFECTED AREA. APPLY A SMALL AMOUNT OF PRODUCT (AN AMOUNT EQUAL TO THE SURFACE AREA OF THE TIP OF A FINGER) ON THE AREA 1-3 TIMES DAILY.

MAY BE COVERED WITH A STERILE BANDAGE

INACTIVE INGREDIENT: WHITE PETROLATUM

USC Triple tube carton

ULTRA SEAL TRIPLE ANTIBIOTIC
neomycin, polymixin, bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42213-360
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU] in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42213-360-80	144 in 1 BOX	09/05/2019	01/01/2022
1	NDC:42213-360-09	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:42213-360-28	1 in 1 CARTON	09/05/2019	01/01/2022
2		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	04/12/2011	01/01/2022

Labeler - Ultra Seal Corporation (085752004)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	pack(42213-360)

Name	Address	ID/FEI	Business Operations
Establishment
ULTRAtab Laboratories, Inc.		151051757	manufacture(42213-360)

Revised: 1/2023

Document Id: f19e7caa-740a-f2c2-e053-2995a90a95b3

Set id: c6dc6040-12c2-44a5-bb1d-b67bc812b298

Version: 5

Effective Time: 20230106

Ultra Seal Corporation