NDC 62565-801 Onetouch Revolution Topical Anesthetic

NDC Product Code 62565-801

NDC 62565-801-01

Package Description: 32 g in 1 JAR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Onetouch Revolution Topical Anesthetic with NDC 62565-801 is a product labeled by Hager Worldwide, Inc.. The generic name of Onetouch Revolution Topical Anesthetic is . The product's dosage form is and is administered via form.

Labeler Name: Hager Worldwide, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hager Worldwide, Inc.
Labeler Code: 62565
Start Marketing Date: 05-05-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Onetouch Revolution Topical Anesthetic Product Label Images

Onetouch Revolution Topical Anesthetic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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.

* Please review the disclaimer below.