TRIPLE ANTIBIOTIC- polymyxin b sulfate,neomycin sulfate,bacitracin ointment 
Shandong Ruian 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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For external use only.

white petrolatum

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

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

First aid antibiotic
External analgesic

• deep or puncture wounds
• animal bites
• serious burns

POLYMYXIN B SULFATE;
NEOMYCIN SULFATE;
BACITRACIN ZINC;
PRAMOXINE HYDROCHLORIDE

store at 10-30°C

• adults and children 2 years of age or older:
• 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 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: ask a doctor

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:
• cuts
• scrapes
• burns

NDC:82199-530-12 28.3 g in 1 TUBE

28.3 g label

NDC:82199-530-11 14.2 g in 1 TUBE

14.2g label

TRIPLE ANTIBIOTIC 
polymyxin b sulfate,neomycin sulfate,bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82199-530
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
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Coloryellow (YELLOW (Translucent)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82199-530-1114.2 g in 1 TUBE; Type 0: Not a Combination Product08/26/2021
2NDC:82199-530-1228.3 g in 1 TUBE; Type 0: Not a Combination Product08/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/26/2021
Labeler - Shandong Ruian Pharmaceutical Co.,Ltd. (723845363)

Revised: 11/2021
Document Id: d0a66c43-7e18-d47f-e053-2995a90a1f05
Set id: cae7322c-17de-0d81-e053-2a95a90a08d7
Version: 3
Effective Time: 20211113
 
Shandong Ruian Pharmaceutical Co.,Ltd.