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Colgate Orabase

Dosage form: paste, dentifrice
Ingredients: Benzocaine 200mg in 1g
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC code: 0126-0065

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

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

for more than 7 days unless directed by a dentist or physician

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?

1-800-962-2345

PRINCIPAL DISPLAY PANEL - 11.9 g Tube Carton

Colgate®

Orabase®
20% Benzocaine

ALCOHOL FREE

Maximum Strength
Oral Pain Reliever

NET WT 0.42 OZ (11.9 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	200 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
butylparaben
carboxymethylcellulose sodium, unspecified form
ethylparaben
methylparaben
mineral oil
pectin
polyethylene glycols
propylparaben
xanthan gum

Packaging
#	Item Code	Package Description
1	NDC:0126-0065-04	1 TUBE in 1 CARTON
1		11.9 g in 1 TUBE
2	NDC:0126-0065-45	1 POUCH in 1 CARTON
2		0.5 g in 1 POUCH

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: 12/2015

Document Id: 367cc743-6f10-4a10-b57d-0fcdc44793dc

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

Version: 2

Effective Time: 20151228

Colgate Oral Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer