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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0065
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
butylparaben 
carboxymethylcellulose sodium, unspecified form 
ethylparaben 
methylparaben 
mineral oil 
pectin 
polyethylene glycols 
propylparaben 
xanthan gum 
Packaging
#Item CodePackage Description
1NDC:0126-0065-041 TUBE in 1 CARTON
111.9 g in 1 TUBE
2NDC:0126-0065-451 POUCH in 1 CARTON
20.5 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/31/2010
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 12/2015
 
Colgate Oral Pharmaceuticals, Inc.

Further information

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