Equaline™

Equaline™
SPL v1
SPL
SPL Set ID 0c8b4476-03f7-45b1-abae-b6f5a298523e
Route
TOPICAL
Published
Effective Date 2013-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [iU]) Neomycin (3.5 mg) Polymyxin B (10000 [iU]) Pramoxine (10 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-31

Description

Drug Facts


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
Bacitracin zinc 500 units First aid antibiotic
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
  • To open: unscrew cap, pull tab remove foil seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient

white petrolatum

Ask A Doctor Before Use
  • on deep or puncture wounds, animal bites, or 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 28.4g Tube Carton

compare to Neosporin® Plus

active ingredients*

equaline™

maximum strength

triple antibiotic plus ointment

polymyxin B sulfate ● bacitracin zinc

neomycin sulfate ● pramoxine hydrochloride

first aid antibiotic/pain relief ointment

NET WT 1 OZ (28.4g)


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
Bacitracin zinc 500 units First aid antibiotic
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)
  • To open: unscrew cap, pull tab remove foil seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient (Inactive ingredient)

white petrolatum

Ask A Doctor Before Use (Ask a doctor before use)
  • on deep or puncture wounds, animal bites, or 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 28.4g Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4g Tube Carton)

compare to Neosporin® Plus

active ingredients*

equaline™

maximum strength

triple antibiotic plus ointment

polymyxin B sulfate ● bacitracin zinc

neomycin sulfate ● pramoxine hydrochloride

first aid antibiotic/pain relief ointment

NET WT 1 OZ (28.4g)


Advanced Ingredient Data


Raw Label Data

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