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Colgate

Colgate Oral Pharmaceuticals, Inc.

Colgate Orabase MAXIMUM STRENGTH ORAL PAIN RELIEVER


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Colgate 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

Colgate

Benzocaine PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0126-0065
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 0.02 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 TUBE
2 NDC:0126-0065-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-08-31


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Be sure to consult your doctor before taking any medication!
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