natureplex™ antibiotic + pain relief

natureplex™ antibiotic + pain relief
SPL v3
SPL
SPL Set ID 0b9e4364-b7ea-44ee-bb27-2804976ee158
Route
topical
Published
Effective Date 2024-12-31
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
cetostearyl alcohol methylparaben mineral oil petrolatum polysorbate 60 propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-12-06

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

First aid to help prevent infection and temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns
Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • 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
  • the affected area may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF FLAPS ON CARTON ARE TORN OR MISSING
Inactive Ingredients

cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

Description

Drug Facts

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: 800-222-1222.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each gram) Purpose
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg External analgesic
Do Not Use
  • in the eyes, nose, or over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Questions Or Comments?

866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If
  • condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
  • a rash or other allergic reaction develops
  • redness, irritation, swelling, or pain persists or increases
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 28 G Tube Carton

Natureplex™

Antibiotic+

Pain Relief

CREAM

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT 1 Oz (28g)


Structured Label Content

Warnings

For external use only.

Uses

First aid to help prevent infection and temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns
Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • 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
  • the affected area may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF FLAPS ON CARTON ARE TORN OR MISSING
Inactive Ingredients (Inactive ingredients)

cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

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: 800-222-1222.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purpose
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg External analgesic
Do Not Use (Do not use)
  • in the eyes, nose, or over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
  • a rash or other allergic reaction develops
  • redness, irritation, swelling, or pain persists or increases
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 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

Natureplex™

Antibiotic+

Pain Relief

CREAM

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT 1 Oz (28g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)