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UltraCare Oral Anesthetic Orange Cream

Dosage form: gel
Ingredients: Benzocaine 231mg in 1mL
Labeler: Ultradent Products, Inc
NDC Code: 51206-206

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.

UltraCare® Oral Anesthetic Gel Orange Cream

Drug Facts

Active Ingredient

Benzocaine 20% w/v

Purpose

Oral Anesthetic

Uses

For the temporary relief of occasional minor irritation and pain associated with

  • minor dental procedures
  • sore mouth and throat
  • minor injury of the gums
  • canker sores
  • minor irritation of the mouth or gums caused by dentures or orthodontic appliances.

Do not use if tamper-evident seal is broken. Store at room temperature.

Warnings

For external use only.

Allergy alert

Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Stop use and ask a doctor if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting.

  • if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.

When using this product avoid contact with eyes.

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.

Directions

Adults and children 2 years of age and older Apply (a thin film) to affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily as directed by a dentist or doctor.

  • Children under 12 years of age Should be supervised in the use of this product.
  • Children under 2 years of age Consult a dentist or doctor.

Other information

Phenylketonurics: Contains Phenylalanine 3mg per gram.

Inactive ingredients

Aspartame, ethyl alcohol, FD&C red #40, glycerin, natural and artficial flavors, Polyethylene glycol, sodium saccharin, titanium dioxide.

Questions or comments?

800.552.5512 or ultradent.com

Manufactured by Ultradent Products, Inc.
505 West Ultradent Drive (10200 South), South Jordan, UT 84095

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Label

Ultracare®
ORAL ANESTHETIC GEL

Orange Cream

30ml REF/UP 3595

ULTRADENT
PRODUCTS, INC.

Made in USA | 1004023.1 071415

ULTRACARE ORAL ANESTHETIC ORANGE CREAM 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-206
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine231 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aspartame 
Alcohol 
FD&C Red No. 40 
Glycerin 
Polyethylene Glycol, Unspecified 
Saccharin Sodium 
Titanium Dioxide 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51206-206-011 BOTTLE, PLASTIC in 1 BOX
130 mL in 1 BOTTLE, PLASTIC
2NDC:51206-206-021 SYRINGE, PLASTIC in 1 BOX
230 mL in 1 SYRINGE, PLASTIC
3NDC:51206-206-0320 SYRINGE, PLASTIC in 1 PACKAGE
31.2 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/01/2016
Labeler - Ultradent Products, Inc (013369916)
Establishment
NameAddressID/FEIOperations
Ultradent Products, Inc013369916MANUFACTURE(51206-206), ANALYSIS(51206-206), LABEL(51206-206)

Revised: 06/2016
 
Ultradent Products, 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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