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

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ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF

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

Children under 2 yrs. of age

Other Information

Inactive Ingredients

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

Questions or information call toll free:

Call 1-855-ATOPALM


AtopalmMoisturizingFirstAidTripleAntibioticProtection

AtopalmMoisturizingFirstAidTripleAntibioticProtectionInner

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF  
bacitracin zinc, neomycin sulfate, polymycin b sulfate, pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0238
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0238-11 in 1 CARTON
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/08/2012
Labeler - Neopharm Co., Ltd. (965502912)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture(51141-0238)

Revised: 6/2015
Document Id: be45bc4b-d94b-4a85-9fa2-5cb7d1880a76
Set id: deaa865f-ec8f-42eb-ac34-fde9985f1391
Version: 5
Effective Time: 20150617
 
Neopharm Co., Ltd.