ATOPALM ORAL PAIN RELIEF - benzocaine gel 
NeoPharm, USA

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 Oral Pain Relief Gel

Active Ingredient

Benzocaine 10%

Purpose

Oral Pain Reliever

Use

for the temporary relief of pain due to toothaches.

Warnings

Allergy alert:

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or a doctor.

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older Children under 12 years of age
Children under 2 years of age

Other information

Inactive Ingredients

PEG-400, PEG-6000, Glycerin, Sodium Saccharin, Sorbic Acid, Flavor

Questions or information?

Call toll free 1-855 ATOPALM – (1-855-286-7256)

Labeling Information

ATOPALM Oral Pain Relief Gel

Fast Temporary Relief of Pain Due to Toothache

Benzocaine 10%


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




Atopalm Oral Gel



Atopalm Oral Gel

ATOPALM ORAL PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0236
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0236-71 in 1 BOX
17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/06/2012
Labeler - NeoPharm, USA (965502912)

Revised: 2/2012
Document Id: c4960e55-2361-47fe-a60d-bf0fbf2d0c66
Set id: b123d1c9-b461-4759-88db-7934ee7fafdd
Version: 1
Effective Time: 20120206
 
NeoPharm, USA