Topcare antibiotic plus pain relief cream

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

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

Otc - keep out of reach of children section

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 25C (68 to 77F)
  • 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

Spl unclassified section

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE,
IL 60007

Ingredients and appearance - Product information

Topcare antibiotic plus pain relief cream- Neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Neomycin sulfate ( UNII: 057Y626693)( Neomycin - UNII: I16QD7X297 ) 3.5 mgin 1 g
Polymyxin b sulfate ( UNII: 19371312D4)( Polymyxin b - UNII: J2VZ07J96K ) 10000 [iU]in 1 g
Pramoxine hydrochloride ( UNII: 88AYB867L5)( Pramoxine - UNII: 068X84E056 ) 10 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Methylparaben ( UNII: A2I8C7HI9T)
Mineral oil ( UNII: T5L8T28FGP)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Petrolatum ( UNII: 4T6H12BN9U)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part333B USA

Labeler - Topco Associates LLC( 006935977)

Establishment

Name ID/FEI Business Operations
Topco Associates LLC 006935977 MANUFACTURE( 36800-381)

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)