Premier Value®

Premier Value®
SPL v3
SPL
SPL Set ID 8efaf795-14c8-4419-ba99-cb7e2e64cf8e
Route
TOPICAL
Published
Effective Date 2018-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

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
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 1-866-923-4914

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

Premier

Value®

Antibiotic Cream

+ Pain Relief

• Neomycin Sulfate • Polymyxin B Sulfate

• Pramoxine HCl

FIRST AID ANTIBIOTIC

PAIN RELIEVING CREAM

NET WT ½ oz (14.2 g)

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED


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 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 (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Questions?

Call 1-866-923-4914

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

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)

Premier

Value®

Antibiotic Cream

+ Pain Relief

• Neomycin Sulfate • Polymyxin B Sulfate

• Pramoxine HCl

FIRST AID ANTIBIOTIC

PAIN RELIEVING CREAM

NET WT ½ oz (14.2 g)

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)