Equaline™

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 FINAL 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	Topical 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: consult a doctor

Do Not Use

in the eyes
over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week

Other Information

store at controlled room temperature
see carton or tube crimp for lot number and expiration date

Inactive Ingredients

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

Ask A Doctor Before Use

on deep or puncture wounds, animal bites, serious burns

Stop Use and Ask A Doctor If

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
a rash or other allergic reaction develops

Principal Display Panel 14.2g Tube Carton

equaline™

compare to active ingredients in

Neosporin® Plus Pain Relief*

maximum strength

antibiotic cream + pain relief

neomycin sulfate • polymyxin B sulfate • pramoxine HCl

first aid antibiotic / pain relieving cream

NET WT 1/2 OZ (14.2g)

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	Topical 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: consult 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
longer than 1 week

Other Information (Other information)

store at controlled room temperature
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

Ask A Doctor Before Use (Ask a doctor before use)

on deep or puncture wounds, animal bites, serious burns

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
a rash or other allergic reaction develops

Principal Display Panel 14.2g Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2g Tube Carton)

equaline™

compare to active ingredients in

Neosporin® Plus Pain Relief*

maximum strength

antibiotic cream + pain relief

neomycin sulfate • polymyxin B sulfate • pramoxine HCl

first aid antibiotic / pain relieving cream

NET WT 1/2 OZ (14.2g)

Advanced Ingredient Data

[{"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"}, {"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": ""}]

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 Topical 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: consult a doctor", "Do not use": "in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week", "Other information": "store at controlled room temperature see carton or tube crimp for lot number and expiration date", "Inactive ingredients": "emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum", "Ask a doctor before use": "on deep or puncture wounds, animal bites, serious burns", "Stop use and ask a doctor if": "condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days a rash or other allergic reaction develops", "PRINCIPAL DISPLAY PANEL - 14.2g Tube Carton": "equaline ™ compare to active ingredients in Neosporin® Plus Pain Relief* maximum strength antibiotic cream + pain relief neomycin sulfate • polymyxin B sulfate • pramoxine HCl first aid antibiotic / pain relieving cream NET WT 1/2 OZ (14.2g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information