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ATOPALM Oral Pain Relief

Dosage form: gel
Ingredients: BENZOCAINE 10g in 100g
Labeler: NeoPharm, USA
NDC Code: 51141-0236

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.

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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

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
  • cut open tip of tube at score mark
Adults and children 2 years of age and older
  • apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or a doctor.
Children under 12 years of age
  • should be supervised in the use of this product.
Children under 2 years of age
  • ask a dentist or a doctor.

Other information
  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

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 PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0236
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 6000 
GLYCERIN 
SACCHARIN SODIUM 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:51141-0236-71 TUBE (TUBE) 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: 02/2012
Document Id: c4960e55-2361-47fe-a60d-bf0fbf2d0c66
Set id: b123d1c9-b461-4759-88db-7934ee7fafdd
Version: 1
Effective Time: 20120206
 
NeoPharm, USA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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