THERAPLUSPLUS  PLUS- neomycin ointment 
Zhejiang Jingwei 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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Drug Facts

Inactive Ingredients mineral oil, petrolatum

Active Ingredient (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxcin B 5,000 units

Purpose

First aid antibiotic

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses first aid to help prevent infection in minor:

-cuts

-scrapes

-burns

Warnings For external use only

Directions

adults and children 2 years of age and older:

-clean the affected area

-apply a small amount of this product to affected area 1 to 3 times daily

-may be covered with a small bandage

Children under 2 years of age: ask a doctor before use


Stop use and ask a doctor if

-symptoms last for more than 7 days, the condition persists or gets worse

-symptoms clear up and then occur again within a few days

-a rahs or other allergic reaction occurs

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

copy of label

THERAPLUSPLUS   PLUS
neomycin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN.41 g  in 100 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN.0035 g  in 100 g
POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B.52 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55621-002-019 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/01/2013
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-002)

Revised: 4/2013
Document Id: 7031fcd6-ab38-4fd0-9188-8a20156aab96
Set id: ea5c0c2a-883a-4713-838d-53e03f4cf798
Version: 5
Effective Time: 20130406
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.