TRIPLE ANTIBIOTIC 01- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Cosmuses Cosmetics (Ningbo) Co., Ltd.

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triple Antibiotic Ointment

Drug Facts

Active Ingredients (in each gram)

Bacitracin Zinc 400U/g

Neomycin Sulfate (3.5mg Neomycin)

Polymyxin B Sulfate 5000U/g

Purpose

Antibiotics

Uses

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

Warnings

For external use only.

Do not use.

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask doctor if

Keep out of reach of children. If ingested, contact Poison Control Center right away.

Directions

Other information

protect from Excessive Heat (40 oC/ 104 oF.)

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin, Glycerin, Ceteareth-20, Isopropyl Myristate, Disodium EDTA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

82953-013

TRIPLE ANTIBIOTIC  01
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82953-013-010.9 g in 1 BAG; Type 0: Not a Combination Product01/04/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00401/04/2024
Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
Establishment
NameAddressID/FEIBusiness Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-013)

Revised: 1/2024
Document Id: 0e1b75c1-96b6-e939-e063-6394a90abffc
Set id: 0e1b23f3-fa1e-f42b-e063-6394a90a3bec
Version: 1
Effective Time: 20240104
 
Cosmuses Cosmetics (Ningbo) Co., Ltd.