ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymycin b sulfate, pramoxine hcl ointment

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF by

Drug Labeling and Warnings

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Neopharm Co., Ltd., NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF

Active Ingredients (each gram contains)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5mg

Polymycin B Sulfate 10,000 units

Pramoxine HCl 10mg

Purpose

First Aid Antibiotic
Topical Analgesic

Uses

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

Warnings

For external use only

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
  

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.

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.
  

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.

Questions or information call toll free:

Call 1-855-ATOPALM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF  
bacitracin zinc, neomycin sulfate, polymycin b sulfate, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [iU]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CHOLESTEROL (UNII: 97C5T2UQ7J)
STEARIC ACID (UNII: 4ELV7Z65AP)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0238-1	1 in 1 CARTON
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/08/2012

Labeler - Neopharm Co., Ltd. (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-0238)