TRIPLE ANTIBIOTIC- polymyxin b sulfate, neomycin sulfate, bacitracin, lidocaine hydrochloride ointment 
Shandong Teking Pharmaceutical Co., Ltd

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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Polymyxin B sulfate 5000units

Neomycin sulfate 3500units

Bacitracin 500units

Lidocaine hydrochloride 40mg

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

First aid to help prevent infection and for the temporary relief of pain in minor:

For external use only

If swallowed, get medical help or contact a Poison Control Center right away.

- 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 2 to 4 times daily and 5 days as a course of treatment.

Light mineral oil

White petrolatum

TRIPLE ANTIBIOTIC OINTMENT

TRIPLE ANTIBIOTIC OINTMENT 1 oz (28.3g)

TRIPLE ANTIBIOTIC 
polymyxin b sulfate, neomycin sulfate, bacitracin, lidocaine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82695-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3500 [USP'U]  in 1 g
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Product Characteristics
Colorwhite (White to light yellow suspension) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82695-0001-328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/23/2022
Labeler - Shandong Teking Pharmaceutical Co., Ltd (617652601)

Revised: 10/2022
Document Id: ebd61edc-4a1d-2a36-e053-2a95a90af97f
Set id: dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63
Version: 4
Effective Time: 20221025
 
Shandong Teking Pharmaceutical Co., Ltd