ATOPALM ORAL PAIN RELIEF- benzocaine gel

ATOPALM Oral Pain Relief by

Drug Labeling and Warnings

ATOPALM Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by NeoPharm, USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ATOPALM ORAL PAIN RELIEF 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0236
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/06/2012

Labeler - NeoPharm, USA (965502912)