ATOPALM Oral Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

ATOPALM Oral Pain Relief

NeoPharm, USA

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
ATOPALM Oral Pain Relief Gel

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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




Labeling Information



Labeling Information

ATOPALM Oral Pain Relief

BENZOCAINE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51141-0236
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 10 g

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
polyethylene glycol 6000
GLYCERIN
saccharin sodium
sorbic acid

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 7 in 1 TUBE
2 NDC:51141-0236-7 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2012-02-06


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Be sure to consult your doctor before taking any medication!
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