Antibiotic Plus Pain Relief

Antibiotic Plus Pain Relief
SPL v4
SPL
SPL Set ID 6fba5890-f48f-4302-a8ac-5087a6e03bd5
Route
TOPICAL
Published
Effective Date 2020-12-03
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 DRUG Active Since 2020-10-16

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 1-800-910-6874

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

up & up

maximum strength

antibiotic cream + pain relief

neomycin sulfate, polymyxin b sulfate, pramoxine HCl

first aid antibiotic / pain relieving cream

helps prevent infection in minor cuts, scrapes and burns plus

maximum strength pain relief

NET WT 0.5 OZ (14.2 g)


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 1-800-910-6874

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)

up & up

maximum strength

antibiotic cream + pain relief

neomycin sulfate, polymyxin b sulfate, pramoxine HCl

first aid antibiotic / pain relieving cream

helps prevent infection in minor cuts, scrapes and burns plus

maximum strength pain relief

NET WT 0.5 OZ (14.2 g)


Advanced Ingredient Data


Raw Label Data

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