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OneTouch Revolution Topical Anesthetic

Dosage form: gel
Ingredients: Benzocaine 200mg in 1g
Labeler: HAGER WORLDWIDE, INC.
NDC Code: 62565-802

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.

OneTouch RevolutionTMTopical Anesthetic Gel Strawberry Ice Flavor

Active ingridients (in each gram)

Benzocaine 20%

Purpose

Oral Anesthetic

Use

Temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic devices

Warnings

Do not use if you have a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other ‘caine’ anesthetics

Do not use for more than 7 days unless directed by a doctor or dentist

Stop using and ask a doctor if swelling, rash or fever develops or if irritation, pain or redness persists of gets worse

Do not exceed recommended dosage.

Keep out of reach of children. In case of overdose, get medical help or Contact Poison Control Center right away

Directions

Adults and children 12 years and over. Press top of container and dispense 0.2 mL. Apply 0.2 mL of gel to the desired area using a cotton swab. Children under 12 should be supervised by an adult. Children under 2 years of age, consult a doctor.

Other information

Store at room temperature
20˚-25˚ C (68˚ - 77˚ F).

Protect from freezing.

Inactive ingredients

Propylene glycol, polyethylene glycol, carbomer, sodium saccharin, povidone, flavoring and FD&C Red No. 40.

Questions or comments

Contact Hager Worldwide at (800) 328-2335

PRINCIPAL DISPLAY PANEL - Jar Label

NDC 62565-802-01
OneTouch
Revolution

Topical Anesthetic Gel

OneTouch Revolution is indicated for anesthesia of accessible mucous membrane.

Strawberry Ice

Net Wt. 1.12 oz (32 g)

ONETOUCH REVOLUTION  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62565-802
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
POLYETHYLENE GLYCOL, UNSPECIFIED 
CARBOXYPOLYMETHYLENE 
SACCHARIN SODIUM 
POVIDONE, UNSPECIFIED 
FD&C RED NO. 40 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62565-802-0132 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/05/2017
Labeler - HAGER WORLDWIDE, INC. (009277971)
Registrant - HAGER WORLDWIDE, INC. (009277971)

Revised: 05/2017
 
HAGER WORLDWIDE, INC.

← See all OneTouch Revolution Topical Anesthetic brands

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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