SPL v3
SPL
SPL Set ID fbc364d7-d8b8-43f5-99cc-290438f3982b
Route
TOPICAL
Published
Effective Date 2022-10-19
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 2022-12-01

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

Warnings

For external use only 

Purpose 

First Aid Antibiotic

First Aid Antibiotic

 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
Drug Facts

Questions? 

Call 1-800-222-1087

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 Tube

Walgreens Children Multi Antibiotic +Pain Relief Cream    NDC 0363-2122-14

Neomycin Sulfate /Polymxin B Sulfate / Pramoxine HCL 

First Aid Anitbiotic / Pain Relieving Cream 

NET WT 0.5 OZ (14.2g)

Principal Dispaly Panel Carton 

Walgreens Children Multi Antibiotic +Pain Relief Cream NDC 0363-2122-14

Neomycin Sulfate /Polymxin B Sulfate /Pramoxine HCL

First Aid Anitbiotic / Pain Relieving Cream

NET WT 0.5 OZ (14.2g)

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

Keep This and All Drugs Out of the Reach of Children

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


Structured Label Content

Uses

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

cuts

scapes

burns

Warnings

For external use only 

Purpose 

First Aid Antibiotic

First Aid Antibiotic

 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
Drug Facts

Questions? 

Call 1-800-222-1087

Other Information 

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients  (Inactive ingredients )

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

Principal Display Panel Tube (Principal Display Panel -Tube)

Walgreens Children Multi Antibiotic +Pain Relief Cream    NDC 0363-2122-14

Neomycin Sulfate /Polymxin B Sulfate / Pramoxine HCL 

First Aid Anitbiotic / Pain Relieving Cream 

NET WT 0.5 OZ (14.2g)

Principal Dispaly Panel Carton  (Principal Dispaly Panel -Carton )

Walgreens Children Multi Antibiotic +Pain Relief Cream NDC 0363-2122-14

Neomycin Sulfate /Polymxin B Sulfate /Pramoxine HCL

First Aid Anitbiotic / Pain Relieving Cream

NET WT 0.5 OZ (14.2g)

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

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.


Advanced Ingredient Data


Raw Label Data

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