THERAPLUSPLUS PLUS- neomycin ointment

TheraPlusPlus by

Drug Labeling and Warnings

TheraPlusPlus by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients mineral oil, petrolatum

ACTIVE INGREDIENT

Active Ingredient (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxcin B 5,000 units

PURPOSE

Purpose

First aid antibiotic

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses first aid to help prevent infection in minor:

-cuts

-scrapes

-burns

WARNINGS

Warnings For external use only

DOSAGE & ADMINISTRATION

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

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 DOCTOR

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAPLUSPLUS   PLUS
neomycin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-002-01	9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	03/01/2013

Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.		530876549	manufacture(55621-002)