NDC 74585-001 Sanimax Hand Sanitizer

Alcohol

NDC Product Code 74585-001

NDC 74585-001-01

Package Description: 30 mL in 1 BOTTLE, PLASTIC

NDC 74585-001-02

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 74585-001-08

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 74585-001-28

Package Description: 3780 mL in 1 BOTTLE, PLASTIC

NDC 74585-001-33

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Sanimax Hand Sanitizer with NDC 74585-001 is a a human over the counter drug product labeled by Ak-pak-ricci. The generic name of Sanimax Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ak-pak-ricci

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Sanimax Hand Sanitizer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 75 mL/100mL

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.

  • ALOE (UNII: V5VD430YW9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • 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

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

Labeler Name: Ak-pak-ricci
Labeler Code: 74585
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-25-2020 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: 12-31-2021 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: N 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.

Sanimax Hand Sanitizer Product Label Images

Sanimax Hand Sanitizer 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 Ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from fire and flame.

Do Not Use

■ on children less than 2 months of age ■ on open skin wounds

When Using This Product

Keep out of eyes, ears, and mouth. In case of eye contact, immediately flush eyes thoriughly with water.

Stop Use And Ask A Doctor If

Irritation or rash occurs. These may be signs of a serious condition

Keep Out Of Reach Of Children

In case of accidential ingestion, contact a doctor or Poison Control Center immediately.

Directions

■ Place enough product on your hands to cover all surfaces. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

■ Store between 15º- 30º (59-86ºF). ■ Avoid freezing and excessive heat above 40º (104ºF) ■ May discolor fabrics or surfaces

Inactive Ingredients

Aloe extract, glycerin, isopropyl alcohol, isopropyl myristate, polyacrylic acid, propylene glycol, tocopheryl acetate, water.

* Please review the disclaimer below.