Topcare ®

Drug Facts

Composition & Product

Active Ingredients

Neomycin (3.5 mg) Polymyxin B (10000 [iU]) Pramoxine (10 mg)

Inactive Ingredients

Methylparaben Mineral Oil Propylene Glycol Water Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-03-21

Medication Information

Description

Drug Facts

Uses

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

cuts
scrapes
burns

Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1

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

Warnings

For external use only.

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

Do Not Use

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

Questions?

Call 1-888-423-0139

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

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

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

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)

Structured Label Content

Uses

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

cuts
scrapes
burns

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)

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

Warnings

For external use only.

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

Do Not Use (Do not use)

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

Questions?

Call 1-888-423-0139

Other Information (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 (Inactive ingredients)

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

Stop Use and Ask A Doctor If (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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds
animal bites
serious burns

Principal Display Panel 14.2 G Tube Carton (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)

Advanced Ingredient Data

[{"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help prevent infection and for the temporary relief of pain or discomfort in minor: cuts scrapes burns", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "55105-1": "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", "Warnings": "For external use only.", "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", "Do not use": "in the eyes over large areas of the body if you are allergic to any of the ingredients", "Questions?": "Call 1-888-423-0139", "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", "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", "Ask a doctor before use if you have": "deep or puncture wounds animal bites serious burns", "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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information