TOPCARE ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

TopCare by

Drug Labeling and Warnings

TopCare by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Uses

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

• cuts
• scrapes
• burns

Warnings

For external use only.

Do not use

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

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• condition persists or gets worse
• you need to use longer than 1 week
• symptoms persist for more than 1 week, or clear up and occur again within a few days
• rash or other allergic reaction develops

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

Directions

Adults and children 2 years of age and older:

• clean the affected area and dry thoroughly
• 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

Other information

• store at 20° to 25°C (68° to 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

Questions?

Call 1-888-423-0139

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DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE,
IL 60007

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

NDC: 36800-381-01

TopCare®
health™

MAXIMUM STRENGTH

Antibiotic Cream + Pain Relief

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCL

OUR PHARMACISTS
RECOMMEND

NET WT 0.5 OZ (14.2 g)

INGREDIENTS AND APPEARANCE

TOPCARE   ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-381
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [iU]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-381-01	1 in 1 CARTON	03/21/2012
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	03/21/2012

Labeler - Topco Associates LLC (006935977)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(36800-381)