NDC 76846-1013 Hand Sanitizer

Hand Sanitizer

NDC Product Code 76846-1013

NDC 76846-1013-1

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 76846-1013 is a a human over the counter drug product labeled by Xiamen Luwei Industrial Co., Ltd. The generic name of Hand Sanitizer is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Xiamen Luwei Industrial Co., Ltd

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 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.

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.

  • METHYL BENZOATE (UNII: 6618K1VJ9T)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Xiamen Luwei Industrial Co., Ltd
Labeler Code: 76846
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: 05-08-2020 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.

Hand Sanitizer Product Label Images

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(S)

Ethyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antiseptic hand rub.

Use

Kills 99.9% of most common germs.

Use in the absence of water or towels.

Warnings

For external use only. Flammable, keep away from fire or flame. Do not mix with detergent or other chemicals.

Do Not Use

Avoid contact with eyes or wound, if product gets into eyes, rinse thoroughly with water.

Otc - When Using

When using this product, do not use in or near the eyes or wound. Use in well ventilated environment.

Otc - Stop Use

Stop using this product if skin irritation occurs and consult a doctor immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, seek medical help immediately.

Directions

  • Dispense product evenly on palms or on material surface and rub your hands until dry. Children should be under adult supervision when using this product. No dilute required.

Other Information

  • Store at room temperature. Product may cause discoloration on certain fabrics or materials.

Inactive Ingredients

Water, Carbomer, Triethanolamine, Aloe extract, Essence.

* Please review the disclaimer below.