Goodsense ®

Goodsense ®
SPL v3
SPL
SPL Set ID 3d79ece7-6b24-4aac-a8a3-e6cdcd605d27
Route
TOPICAL
Published
Effective Date 2020-01-24
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 2012-03-21

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

First aid to help prevent infection and 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: 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
Warnings

For external use only.

Not for prolonged use.

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

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
Other Information
  • store at 15 to 30°C (59 to 86°F)
  • contents filled by weight, not volume
  • Tamper Evident:DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING
Inactive Ingredients

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

Questions Or Comments?

866-323-0107

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 14.2 G Tube Carton

GOODSENSE ®

NDC 50804-076-01

Maximum Strength

Antibiotic Cream + Pain Relief

Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Pain Relieving Cream

Compare to active ingredients in

Neosporin ®+ Pain Relief*

100%

SATISFACTION

GUARANTEED

NET WT 0.5 oz (14.2 g)


Structured Label Content

Uses

First aid to help prevent infection and 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: 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
Warnings

For external use only.

Not for prolonged use.

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

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
Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • contents filled by weight, not volume
  • Tamper Evident:DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

866-323-0107

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 14.2 G Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton)

GOODSENSE ®

NDC 50804-076-01

Maximum Strength

Antibiotic Cream + Pain Relief

Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Pain Relieving Cream

Compare to active ingredients in

Neosporin ®+ Pain Relief*

100%

SATISFACTION

GUARANTEED

NET WT 0.5 oz (14.2 g)


Advanced Ingredient Data


Raw Label Data

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