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
Now 100% More!

NET WT 0.42 OZ (12 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) Benzocaine0.02 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:0126-0065-041 TUBE (TUBE) in 1 CARTON
112 g in 1 TUBE
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: 08/2010
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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