Label: ONETOUCH REVOLUTION TOPICAL ANESTHETIC- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62565-801-01 - Packager: HAGER WORLDWIDE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 15, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingridients (in each gram)
- Purpose
- Use
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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
- STOP USE
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- Directions
- Other information
- Inactive ingredients
- Questions or comments
- PRINCIPAL DISPLAY PANEL - Jar Label
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INGREDIENTS AND APPEARANCE
ONETOUCH REVOLUTION TOPICAL ANESTHETIC
benzocaine gelProduct 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)
