meijer distribution, inc. first aid antibiotic + pain relief cream drug facts

meijer distribution, inc. first aid antibiotic + pain relief cream drug facts
SPL v4
SPL
SPL Set ID f0892a30-8a88-44e8-ab04-0e87c12f9c44
Route
topical
Published
Effective Date 2024-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
neomycin (3.5 mg) pramoxine (10 mg) polymyxin b (10000 [USP'U])
Inactive Ingredients
methylparaben mineral oil poloxamer 188 propylene glycol water petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2021-04-20

Purpose

First aid antibiotic External analgesic

Description

Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg


Medication Information

Warnings

For external use only.

Uses

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

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

External analgesic

Directions
  • adults and children 2 years of age or 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
  • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor
Other Information
  • store at 20o-25oC (68o-77oF)
Inactive Ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Description

Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg

Principal Display Panel

meijer®

MAXIMUM STRENGTH

First Aid Antibiotic + Pain Relief Cream

Long Lasting Infection Protection + Pain Relief

FIRST AID ANTIBIOTIC | PAIN RELIEVING CREAM

Helps Prevent Infection & Temporarily Relieves Pain Due to Minor Cuts, Scrapes & Burns

COMPARE TO NEOSPORIN® + PAIN RELIEF CREAM ACTIVE INGREDIENTS

Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl

NET WT 1 OZ (28 g)

Do Not Use
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Gram)

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns

Structured Label Content

Warnings

For external use only.

Uses

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

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

External analgesic

Directions
  • adults and children 2 years of age or 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
  • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor
Other Information (Other information)
  • store at 20o-25oC (68o-77oF)
Inactive Ingredients (Inactive ingredients)

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Principal Display Panel

meijer®

MAXIMUM STRENGTH

First Aid Antibiotic + Pain Relief Cream

Long Lasting Infection Protection + Pain Relief

FIRST AID ANTIBIOTIC | PAIN RELIEVING CREAM

Helps Prevent Infection & Temporarily Relieves Pain Due to Minor Cuts, Scrapes & Burns

COMPARE TO NEOSPORIN® + PAIN RELIEF CREAM ACTIVE INGREDIENTS

Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl

NET WT 1 OZ (28 g)

Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions Or Comments? (Questions or comments?)

1-800-719-9260

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns

Advanced Ingredient Data


Raw Label Data

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