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OneTouch Revolution Topical Anesthetic

Dosage form: gel
Ingredients: Benzocaine 200mg in 1g
Labeler: HAGER WORLDWIDE, INC.
NDC Code: 62565-801

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 Revolution Topical Anesthetic Gel Cool Mint 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

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if they or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Do not exceed reccommended dosage

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

Do not use

  • for teething
  • in children under 2 years of age

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, ethyl alcohol, methylparaben, propyl paraben, flavoring, D&C Yellow No. 10 and FD&C Blue No. 1.

Questions or comments

Contact Hager Worldwide at (800) 328-2335

PRINCIPAL DISPLAY PANEL - Jar Label

NDC 62565-801-01
OneTouch
Revolution

Topical Anesthetic Gel

ORAL pain relief for teeth and accessible mucous membrane.

Cool Mint

Net Wt. 1.12 oz (32 g)

ONETOUCH REVOLUTION  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62565-801
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 
ALCOHOL 
METHYLPARABEN 
PROPYLPARABEN 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62565-801-0132 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)

 
HAGER WORLDWIDE, INC.

← See all OneTouch Revolution Topical Anesthetic brands

Medically reviewed on Jul 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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