Safeway™

Safeway™
SPL v1
SPL
SPL Set ID 9ce7bb16-d30c-4b32-ba19-48edda8ebc9b
Route
TOPICAL
Published
Effective Date 2013-03-12
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 FINAL Active Since 2012-03-21

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 50570-1

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week
Section 55105-1
Active ingredients (each gram contains) Purpose
Neomycin sulfate 3.5mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10mg Topical 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: Consult a doctor.

Other Information
  • store at controlled room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

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

Ask A Doctor Before Use
  • on deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops
Principal Display Panel 14.2g Tube Carton

Maximum Strength

NDC 21130-076-01

Antibiotic Cream + Pain Relief

• Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

NET WT ½ OZ (14.2g)

SAFEWAY


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 50570-1 (50570-1)

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week
Section 55105-1 (55105-1)
Active ingredients (each gram contains) Purpose
Neomycin sulfate 3.5mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10mg Topical 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: Consult a doctor.

Other Information (Other information)
  • store at controlled room temperature
  • 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

Ask A Doctor Before Use (Ask a doctor before use)
  • on deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops
Principal Display Panel 14.2g Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2g Tube Carton)

Maximum Strength

NDC 21130-076-01

Antibiotic Cream + Pain Relief

• Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

NET WT ½ OZ (14.2g)

SAFEWAY


Advanced Ingredient Data


Raw Label Data

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