SPL v3
SPL
SPL Set ID f4feccc3-ac25-4d8a-9b68-9a24f755524a
Route
TOPICAL
Published
Effective Date 2022-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polymyxin B (10000 [USP'U]) Neomycin (3.5 mg) Pramoxine (10 mg)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Stearate Se Methylparaben Mineral Oil Phosphoric Acid Propylene Glycol Water White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-15

Description

Neomycin Sulfate (3.5mg)                         First Aid Antibiotic Polymixin B Sulfate (10,000 units)              First Aid Antibiotic Pramoxine Hydrochloride (10 mg)               External Analgesic

Purpose

Neomycin Sulfate (3.5mg)                         First Aid Antibiotic Polymixin B Sulfate (10,000 units)              First Aid Antibiotic Pramoxine Hydrochloride (10 mg)               External Analgesic


Medication Information

Purpose

Neomycin Sulfate (3.5mg)                         First Aid Antibiotic Polymixin B Sulfate (10,000 units)              First Aid Antibiotic Pramoxine Hydrochloride (10 mg)               External Analgesic

Description

Neomycin Sulfate (3.5mg)                         First Aid Antibiotic Polymixin B Sulfate (10,000 units)              First Aid Antibiotic Pramoxine Hydrochloride (10 mg)               External Analgesic

Uses

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

  • cuts 
  • scapes 
  • burns
Section 55106-9

Warning

For external use only.

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
  • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor
Other Information 
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients  

Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Phosphoric Acid, Propylene Glycol, Purified Water, White Petrolatum

Principal Display Panel 0.5oz Tube

Walgreens Multi-Antibiotic With Pain Relief Cream 

Maximum Strength  

Neomycin Sulfate / Polymyxin B Sulfate / Pramoxine HCL 

NET WT 0.5 oz (14 g)

Principal Display Panel 0.5oz Carton 

Walgreens Multi-Antibiotic With Pain Relief Cream

Maximum Strength

Neomycin Sulfate / Polymyxin B Sulfate / Pramoxine HCL

NET WT 0.5 oz (14 g)

Keep This and All Drugs Out of the Reach of Children

If swallowed, get medical help or contact Poison Control Center right away.

Active Ingredients (in Each Gram)            Purpose 

Neomycin Sulfate (3.5mg)                         First Aid Antibiotic

Polymixin B Sulfate (10,000 units)              First Aid Antibiotic

Pramoxine Hydrochloride (10 mg)               External Analgesic


Structured Label Content

Uses

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

  • cuts 
  • scapes 
  • burns
Section 55106-9 (55106-9)

Warning

For external use only.

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
  • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor
Other Information  (Other information )
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients  

Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Phosphoric Acid, Propylene Glycol, Purified Water, White Petrolatum

Principal Display Panel 0.5oz Tube (Principal Display panel 0.5oz Tube)

Walgreens Multi-Antibiotic With Pain Relief Cream 

Maximum Strength  

Neomycin Sulfate / Polymyxin B Sulfate / Pramoxine HCL 

NET WT 0.5 oz (14 g)

Principal Display Panel 0.5oz Carton  (Principal Display panel 0.5oz Carton )

Walgreens Multi-Antibiotic With Pain Relief Cream

Maximum Strength

Neomycin Sulfate / Polymyxin B Sulfate / Pramoxine HCL

NET WT 0.5 oz (14 g)

Keep This and All Drugs Out of the Reach of Children (Keep this and all drugs out of the reach of children)

If swallowed, get medical help or contact Poison Control Center right away.

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

Neomycin Sulfate (3.5mg)                         First Aid Antibiotic

Polymixin B Sulfate (10,000 units)              First Aid Antibiotic

Pramoxine Hydrochloride (10 mg)               External Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)