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

Warnings

For external use only.

Uses

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

cuts
scrapes
burns

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

Description

Drug Facts

Questions?

Call 1-888-423-0139

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

Do Not Use

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

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

Warnings

For external use only.

Uses

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

cuts
scrapes
burns

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 (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

Questions?

Call 1-888-423-0139

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

Do Not Use (Do not use)

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

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