ONETOUCH REVOLUTION TOPICAL ANESTHETIC- benzocaine gel

OneTouch Revolution by

Drug Labeling and Warnings

OneTouch Revolution by is a Otc medication manufactured, distributed, or labeled by HAGER WORLDWIDE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 USE

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

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage.

KEEP OUT OF REACH OF CHILDREN

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

ONETOUCH REVOLUTION  TOPICAL ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62565-801
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62565-801-01	32 g in 1 JAR; Type 0: Not a Combination Product	05/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	05/05/2017

Labeler - HAGER WORLDWIDE, INC. (009277971)

Registrant - HAGER WORLDWIDE, INC. (009277971)