ORABASE BENZOCAINE  PURPLE ICE- benzocaine paste, dentifrice 
Colgate Oral Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Orabase® 20% Benzocaine - Purple Ice

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Use

for 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

Other information

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

Inactive ingredients

mineral oil, cellulose gum, pectin, xanthan gum, polyethylene, flavor

Questions or comments?

call toll-free 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)

PRINCIPAL DISPLAY PANEL - 11.9 g Tube Carton
ORABASE BENZOCAINE   PURPLE ICE
benzocaine paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0126-0082
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 19.8 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Mineral Oil (UNII: T5L8T28FGP)  
Xanthan Gum (UNII: TTV12P4NEE)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Pectin (UNII: 89NA02M4RX)  
High Density Polyethylene (UNII: UG00KM4WR7)  
Isoxaflutole (UNII: 0T9R0O0EYT)  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE, MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0126-0082-04 12 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2012
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 2/2013
Document Id: a983588f-a259-44e8-b3f0-248d58b05ef3
Set id: 387f52e1-157a-4b9e-8f98-9001c6880786
Version: 1
Effective Time: 20130201
 
Colgate Oral Pharmaceuticals, Inc.