kroger co. antibiotic cream + pain relief drug facts

kroger co. antibiotic cream + pain relief drug facts
SPL v3
SPL
SPL Set ID 91828614-d0d1-472f-802f-43f473860125
Route
topical
Published
Effective Date 2019-02-14
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 2019-02-14

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

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

1-800-632-6900

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
Package/label Principal Display Panel

COMPARE TO active ingredients of NEOSPORIN® + PAIN RELIEF CREAM

See back panel

Maximum Strength

Antibiotic Cream + Pain Relief

First Aid Antibiotic/Pain Relieving Cream

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT .5 OZ (14g)


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

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?)

1-800-632-6900

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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO active ingredients of NEOSPORIN® + PAIN RELIEF CREAM

See back panel

Maximum Strength

Antibiotic Cream + Pain Relief

First Aid Antibiotic/Pain Relieving Cream

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT .5 OZ (14g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)