NDC 75540-253 Hyalolex Hand Sanitizer

Hand Sanitizer

NDC Product Code 75540-253

NDC 75540-253-02

Package Description: 59 mL in 1 BOTTLE

NDC 75540-253-04

Package Description: 118 mL in 1 BOTTLE

NDC 75540-253-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Hyalolex Hand Sanitizer with NDC 75540-253 is a a human over the counter drug product labeled by India Globalization Capital, Inc.. The generic name of Hyalolex Hand Sanitizer is hand sanitizer. The product's dosage form is liquid and is administered via topical form.

Labeler Name: India Globalization Capital, Inc.

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.

Hyalolex 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 70 mL/100mL
  • ALCOHOL 70 mL/100mL
  • ALCOHOL 70 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.

  • PROPYLENE GLYCOL 1-STEARATE (UNII: 32I3MRN561)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LEMON OIL (UNII: I9GRO824LL)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

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.
  • 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.
  • 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: India Globalization Capital, Inc.
Labeler Code: 75540
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: 10-19-2020 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.

Hyalolex Hand Sanitizer Product Label Images

Hyalolex 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

Other

  • This is a hand sanitizer manufactured according to the
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
  • The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.Glycerol (1.45% v/v).Hydrogen peroxide (0.125% v/v).Sterile distilled water or boiled cold water.The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial

Use

Hand Sanitizer to help reduce germs on the skin

Warnings

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

Do Not Use

In or near eyes. In case of contact, rinse eyes thoroughly with water

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly 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. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use if irritation appears

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Wet hands with the product and briskly rub hands together until dry.Supervise children under 6 years in use of this product

Other Information

  • Store between 20-25C (68-77F)May discolor certain fabrics

Inactive Ingredients

Purified water USP, acrylate copolymer, glycerin, carbomer, propylene glycol, aloe leaf extract, lemon oil, hydroxypropyl methylcellulose, tocopheryl acetate

* Please review the disclaimer below.