bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride

bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride
SPL v1
SPL
SPL Set ID 56d941b5-3b4d-44c9-b800-714a7c18f4b9
Route
topical
Published
Effective Date 2013-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (500 [USP'U]) neomycin (3.5 mg) polymyxin b (10000 [USP'U]) pramoxine (10 mg)
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2008-07-01

Purpose

First aid antibiotic/Pain reliever

Description

(in each gram) Bacitracin zinc, USP 500 units Neomycin Sulfate, USP 3.5 mg Polymyxin B sulfate, USP 10,000 units Pramoxine hydrochloride, USP 10 mg


Medication Information

Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Uses

First aid to help prevent infection and for temporary relief of pain or discomfort due to

  • minor cuts
  • scrapes
  • burns
Purpose

First aid antibiotic/Pain reliever

Other Information
  • Store at 59º -86ºF (15º -30ºC).
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Description

(in each gram) Bacitracin zinc, USP 500 units Neomycin Sulfate, USP 3.5 mg Polymyxin B sulfate, USP 10,000 units Pramoxine hydrochloride, USP 10 mg

Otc Purpose

First aid antibiotic/Pain reliever

Otc Do Not Use
  • in the eyes
  • over large areas of the body
Inactive Ingredient

White petrolatum

Otc Active Ingredient

(in each gram)

Bacitracin zinc, USP 500 units

Neomycin Sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 10,000 units

Pramoxine hydrochloride, USP 10 mg

2  Dosage & Administration

Adults and children 2 years and older:

  • clean affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years: ask a doctor

Otc Questions Or Comments?

1-800-632-6900

Otc When Using This Product
  • do not use longer than 1 week unless directed by a doctor
Otc Stop Use and Ask A Doctor If
  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops
Otc Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

Kroger ®

QUALITY GUARANTEED

Compare to the active ingredients of NEOSPORIN® PLUS.

*See Back Panel.

maximum strength

TRIPLE ANTIBIOTIC OINTMENT

PLUS PAIN RELIEF

• Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

• First aid antibiotic plus topical pain reliever

NET WT 1 OZ (28 g)

08230611xx VC108014

CARTON LABEL
Otc Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns[/S][/S][/S]

Structured Label Content

Warnings (WARNINGS)

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Uses (USES)

First aid to help prevent infection and for temporary relief of pain or discomfort due to

  • minor cuts
  • scrapes
  • burns
Other Information (OTHER INFORMATION)
  • Store at 59º -86ºF (15º -30ºC).
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Otc Purpose (OTC - PURPOSE)

First aid antibiotic/Pain reliever

Otc Do Not Use (OTC - DO NOT USE)
  • in the eyes
  • over large areas of the body
Inactive Ingredient (INACTIVE INGREDIENT)

White petrolatum

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

(in each gram)

Bacitracin zinc, USP 500 units

Neomycin Sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 10,000 units

Pramoxine hydrochloride, USP 10 mg

2  Dosage & Administration (2  DOSAGE & ADMINISTRATION)

Adults and children 2 years and older:

  • clean affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years: ask a doctor

Otc Questions Or Comments? (OTC - QUESTIONS OR COMMENTS?)

1-800-632-6900

Otc When Using This Product (OTC - WHEN USING THIS PRODUCT)
  • do not use longer than 1 week unless directed by a doctor
Otc Stop Use and Ask A Doctor If (OTC - STOP USE AND ASK A DOCTOR IF)
  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops
Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Kroger ®

QUALITY GUARANTEED

Compare to the active ingredients of NEOSPORIN® PLUS.

*See Back Panel.

maximum strength

TRIPLE ANTIBIOTIC OINTMENT

PLUS PAIN RELIEF

• Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

• First aid antibiotic plus topical pain reliever

NET WT 1 OZ (28 g)

08230611xx VC108014

CARTON LABEL
Otc Ask A Doctor Before Use If You Have (OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • deep or puncture wounds
  • animal bites
  • serious burns[/S][/S][/S]

Advanced Ingredient Data


Raw Label Data

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