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Colgate Orabase

Dosage form: paste, dentifrice
Ingredients: Benzocaine 0.02g in 1g
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC Code: 0126-0065

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.

Colgate®
Orabase®
MAXIMUM STRENGTH
ORAL PAIN RELIEVER

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain associated with canker sores, due to minor irritation or injury of the mouth and gums, or due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

Do not use

for more than 7 days unless directed by a dentist or physician
if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

When using this product

do not exceed recommended dosage
avoid contact with eyes
localized allergic reactions may occur after prolonged or repeated use

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens

Keep out of reach of children. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

adults and children 2 years and older: gently dab paste on the site of irritation with a cotton swab or fingertip
allow to remain in place at least 1 minute and then spit out
use up to 4 times daily or as directed by a dentist or physician
children under 12 years of age should be supervised in the use of the product
children under 2 years of age: consult a dentist or physician

Other information

store at controlled room temperature, 68-77°F (20-25°C)

Inactive ingredients

butylparaben, cellulose gum, ethylparaben, flavor, methylparaben, mineral oil, pectin, polyethylene, propylparaben, xanthan gum

Questions or comments?

call toll free 1-800-962-2345

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

Colgate®

Orabase®

#1 Recommended by Pharmacists

VALUE PACK
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NET WT 0.42 OZ (12 g)

COLGATE ORABASE
benzocaine paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0126-0065
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (Benzocaine)	Benzocaine	0.02 g in 1 g

Packaging
#	Item Code	Package Description
1	NDC:0126-0065-04	1 TUBE (TUBE) in 1 CARTON
1		12 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/31/2010

Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 08/2010

Document Id: 4f6f8f15-8007-46c8-9319-9d62e2c9e931

Set id: 4dbcc75e-8d36-4348-897c-72d90bb4dcc7

Version: 1

Effective Time: 20100830

Colgate Oral Pharmaceuticals, Inc.

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.