Modern Chemical

SKU: MC1GG Category:

Description

FDA approved gel with 70% alcohol. Comes in 1 gallon, 32oz, 16oz and 08oz with pumps.

Hand Sanitizer with NDC 75594-170 is a a human over the counter drug product labeled by Commercial Beverage Concepts, Llc. The generic name of Hand Sanitizer is alcohol. The product’s dosage form is gel and is administered via topical form.

Labeler Name: Commercial Beverage Concepts, Llc

Dosage Form: Gel – A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug

Hand Sanitizer Active Ingredient(s)

 

  • ALCOHOL .7 mL/mL

Inactive Ingredient(s)

 

  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • ADENOSINE PHOSPHATE (UNII: 415SHH325A)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

 

Administration Route(s)

 

  • Topical – Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical – Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

 

Product Labeler Information

 

Labeler Name: Commercial Beverage Concepts, Llc
Labeler Code: 75594
FDA Application Number: part333E

Marketing Category: OTC MONOGRAPH NOT FINAL – A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date: 06-01-2020
Listing Expiration Date: 12-31-2021
Exclude Flag: N

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