ATOPALM FIRST AID TRIPLE ANTIBIOTIC PLUS PAIN RELIEF   - bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride ointment 
Neopharm Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymycin B Sulfate 5000 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
  • over large areas of the body
  • 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 immediately

Directions

Adults and children 2 years of age and older

Children under 2 yrs. of age

Other Information

Inactive Ingredients

WATER, ISOPROPYL MYRISTATE, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE,
STEARIC ACID, MYRISTOYL/PALMITOYL OXOSTEARIDE/ARACHAMIDE MEA, CHOLESTEROL,
BENZYL ALCOHOL.

Questions or information call toll free:

Call 1-855-ATOPALM

First Aid Triple Antibiotic Pain Relieving Ointment
Maximum Strength without a prescription

ATOPALM
FIRST AID TRIPLE ANTIBIOTIC PROTECTION
in a Moisturizing Ointment Based on US Patented MLE Technology

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


ATOPALM
Moisturizing First Aid Triple Antibiotic Protection + Pain Relief
Net wt. 1oz/28.3g


Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
Made in Korea

Bacitracin Zinc ■ Neomycin Sulfate
Polymyxin B Sulfate ■ Pramoxine Hydrochloride

Product Labeling

ATOPALM First Aid Antibiotic plus pain

ATOPALM First Aid Antibiotic plus pain

ATOPALM First Aid Antibiotic plus pain


ATOPALM FIRST AID TRIPLE ANTIBIOTIC PLUS PAIN RELIEF  
bacitracin zinc, neomycin sulfate, polymycin b sulfate, pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0234
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE5000 [iU]  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL MYRISTATE 
POLYSORBATE 80 
GLYCERYL MONOSTEARATE 
STEARIC ACID 
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA 
CHOLESTEROL 
BENZYL ALCOHOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:51141-0234-11 TUBE ( TUBE) in 1 CARTONcontains a TUBE
128.3 g in 1 TUBEThis package is contained within the CARTON (51141-0234-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/17/2012

Labeler - Neopharm Co., Ltd. (965502912)

Revised: 08/2012 Neopharm Co., Ltd.