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

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

Purpose

First aid antibiotic/Pain reliever


Medication Information

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

Uses

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

  • minor cuts
  • scrapes
  • burns
Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Otc Purpose

First aid antibiotic/Pain reliever

Otc Do Not Use
  • in the eyes
  • over large areas of the body
Other Information
  • Store at 59º -86ºF (15º -30ºC).
  • Before using any medication, read all label directions. Keep carton, it contains important information.
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

Uses (USES)

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

  • minor cuts
  • scrapes
  • burns
Warnings (WARNINGS)

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients
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
Other Information (OTHER INFORMATION)
  • Store at 59º -86ºF (15º -30ºC).
  • Before using any medication, read all label directions. Keep carton, it contains important information.
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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