TRIPLE ANTIBIOTIC- polymyxin b sulfate,neomycin sulfate,bacitracin zinc,lidocaine hydrochloride 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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POLYMYXIN B SULFATE;
NEOMYCIN SULFATE;
BACITRACIN ZINC;
LIDOCAINE HYDROCHLORIDE

First aid antibiotic
External analgesic

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

For external use only

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

• deep or puncture wounds
• animal bites
• serious burns

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

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

store at 10°C-30°C

petrolatum

NDC: 82199-531-13 14.2 g in 1 TUBE

14.2g label

NDC: 82199-531-14 28.3 g in 1 TUBE

28.3g label

TRIPLE ANTIBIOTIC 
polymyxin b sulfate,neomycin sulfate,bacitracin zinc,lidocaine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82199-531
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3500 [USP'U]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82199-531-1314.2 g in 1 TUBE; Type 0: Not a Combination Product11/18/2021
2NDC:82199-531-1428.3 g in 1 TUBE; Type 0: Not a Combination Product11/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B11/18/2021
Labeler - Shandong Ruian Pharmaceutical Co.,Ltd. (723845363)

Revised: 11/2021
Document Id: d11d53d1-f961-dfe9-e053-2995a90aa681
Set id: d11d53d1-f960-dfe9-e053-2995a90aa681
Version: 1
Effective Time: 20211118
 
Shandong Ruian Pharmaceutical Co.,Ltd.