Atopalm First Aid Triple Antibiotic Protection Moisturizing Ointment And Pain Relief

Atopalm First Aid Triple Antibiotic Protection Moisturizing Ointment And Pain Relief
SPL v5
SPL
SPL Set ID deaa865f-ec8f-42eb-ac34-fde9985f1391
Route
TOPICAL
Published
Effective Date 2015-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [iU]) Neomycin (3.5 mg) Polymyxin B (10000 [iU]) Pramoxine (10 mg)
Inactive Ingredients
Petrolatum Light Mineral Oil Cholesterol Stearic Acid Myristoyl/palmitoyl Oxostearamide/arachamide Mea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-08-08

Description

Bacitracin Zinc 500 units Neomycin Sulfate 3.5mg Polymycin B Sulfate 10,000 units Pramoxine HCl 10mg

Purpose

First Aid Antibiotic Topical Analgesic


Medication Information

Purpose





First Aid Antibiotic

Topical Analgesic

Description

Bacitracin Zinc 500 units Neomycin Sulfate 3.5mg Polymycin B Sulfate 10,000 units Pramoxine HCl 10mg

Uses

First aid to help prevent infection and for the temporary relief of pain and discomfort of minor cuts, scrapes, burns.

Section 51945-4


Warnings

For external use only

Directions

Adults and children 2 years of age and older

  • clean the affected area and dry throughly

  • apply a small 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 yrs. of age

  • Consult a doctor.

Do Not Use
  • if you are allergic to any of the ingredients
  • in or near the eyes
  • longer than 1 week
  • over large areas of the body

Other Information
  • store at 68° – 77°F (20° – 25°C)
  • see carton flap or tube crimp for lot number and expiration date
Inactive Ingredients

PETROLATUM, LIGHT MINERAL OIL, STEARIC ACID, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHMIDE MEA.

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.

Keep Out of Reach of Children.

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

Active Ingredients (each Gram Contains)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5mg

Polymycin B Sulfate 10,000 units

Pramoxine HCl 10mg

Questions Or Information Call Toll Free:

Call 1-855-ATOPALM

Atopalm First Aid Triple Antibiotic Protection Moisturizing Ointment and Pain Relief



Structured Label Content

Uses

First aid to help prevent infection and for the temporary relief of pain and discomfort of minor cuts, scrapes, burns.

Section 51945-4 (51945-4)


Purpose





First Aid Antibiotic

Topical Analgesic

Warnings

For external use only

Directions

Adults and children 2 years of age and older

  • clean the affected area and dry throughly

  • apply a small 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 yrs. of age

  • Consult a doctor.

Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in or near the eyes
  • longer than 1 week
  • over large areas of the body

Other Information
  • store at 68° – 77°F (20° – 25°C)
  • see carton flap or tube crimp for lot number and expiration date
Inactive Ingredients

PETROLATUM, LIGHT MINERAL OIL, STEARIC ACID, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHMIDE MEA.

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (each Gram Contains) (Active Ingredients (each gram contains))

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5mg

Polymycin B Sulfate 10,000 units

Pramoxine HCl 10mg

Questions Or Information Call Toll Free: (Questions or information call toll free:)

Call 1-855-ATOPALM

Atopalm First Aid Triple Antibiotic Protection Moisturizing Ointment and Pain Relief (ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF)



Advanced Ingredient Data


Raw Label Data

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