TRIPLE ANTIBIOTIC 01- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

triple antibiotic by

Drug Labeling and Warnings

triple antibiotic by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

• in or near the eyes
• for diaper rash; ask a doctor

ASK DOCTOR

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

STOP USE

Stop use and ask doctor if

• condition worsens or if symptoms persist for more than 7 days
• symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

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

Directions

• apply to affected area not more than 3 to 4 times daily
• children under 2 years do not use; ask a doctor

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC  01
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-013
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-013-01	0.9 g in 1 BAG; Type 0: Not a Combination Product	01/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	01/04/2024

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-013)