SPL v3
SPL
SPL Set ID dad0574e-eb9c-429e-8fc0-e7d4c6b50b85
Route
TOPICAL
Published
Effective Date 2022-09-19
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 2022-10-01

Description

Neomycin Sulfate (3.5mg)  Polymixin B Sulfate (10,000 units)  Pramoxine Hydrochloride (10 mg) 

Purpose

Neomycin Sulfate                      First Aid Antibiotic Polymixin B Sulfate                   First Aid Antibiotic Pramoxine Hydrochloride           External Analgesic


Medication Information

Purpose

Neomycin Sulfate                      First Aid Antibiotic

Polymixin B Sulfate                   First Aid Antibiotic

Pramoxine Hydrochloride           External Analgesic

Description

Neomycin Sulfate (3.5mg)  Polymixin B Sulfate (10,000 units)  Pramoxine Hydrochloride (10 mg) 

Uses

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

cuts

scapes

burns

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
Warnings 

For external use only.

Drug Facts 

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 Primary Panel Tube 

Rite Aid Multi Antibiotic Cream with Pain Relief

NDC 11822-2163-1

  • Neomycin Sulfate
  • Polymixin B Sulfate
  • Pramoxine HCL

First aid Antibiotic Pain Relieving Cream

NET WT 1.0 OZ (28g)

Principal Primary Panel Carton 

Rite Aid Multi Antibiotic Cream with Pain Relief

NDC 11822-2163-1

  • Neomycin Sulfate
  • Polymixin B Sulfate 
  • Pramoxine HCL 

First aid Antibiotic Pain Relieving Cream

NET WT 1.0 OZ (28g) 

Keep This and All Drugs Out of the Reach of Children

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

Active Ingredient                                

Neomycin Sulfate (3.5mg) 

Polymixin B Sulfate (10,000 units) 

Pramoxine Hydrochloride (10 mg) 


Structured Label Content

Uses

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

cuts

scapes

burns

Purpose

Neomycin Sulfate                      First Aid Antibiotic

Polymixin B Sulfate                   First Aid Antibiotic

Pramoxine Hydrochloride           External Analgesic

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
Warnings 

For external use only.

Drug Facts 

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 Primary Panel Tube  (Principal Primary Panel -Tube )

Rite Aid Multi Antibiotic Cream with Pain Relief

NDC 11822-2163-1

  • Neomycin Sulfate
  • Polymixin B Sulfate
  • Pramoxine HCL

First aid Antibiotic Pain Relieving Cream

NET WT 1.0 OZ (28g)

Principal Primary Panel Carton  (Principal Primary Panel -Carton )

Rite Aid Multi Antibiotic Cream with Pain Relief

NDC 11822-2163-1

  • Neomycin Sulfate
  • Polymixin B Sulfate 
  • Pramoxine HCL 

First aid Antibiotic Pain Relieving Cream

NET WT 1.0 OZ (28g) 

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 Ingredient                                 (Active ingredient                                )

Neomycin Sulfate (3.5mg) 

Polymixin B Sulfate (10,000 units) 

Pramoxine Hydrochloride (10 mg) 


Advanced Ingredient Data


Raw Label Data

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