NDC 77394-103 Lather - Lavender Hand Sanitizer Wipes With Moisturizing Aloe

Ethyl Alcohol

NDC Product Code 77394-103

NDC 77394-103-01

Package Description: 1 SOLUTION in 1 POUCH

NDC 77394-103-10

Package Description: 10 SOLUTION in 1 POUCH

NDC Product Information

Lather - Lavender Hand Sanitizer Wipes With Moisturizing Aloe with NDC 77394-103 is a a human over the counter drug product labeled by Lather, Inc.. The generic name of Lather - Lavender Hand Sanitizer Wipes With Moisturizing Aloe is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Lather, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Lather - Lavender Hand Sanitizer Wipes With Moisturizing Aloe 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 6.5 mL/1

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • OAT (UNII: Z6J799EAJK)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • CUCUMBER (UNII: YY7C30VXJT)

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: Lather, Inc.
Labeler Code: 77394
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: 05-28-2020 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.

Lather - Lavender Hand Sanitizer Wipes With Moisturizing Aloe Product Label Images

Lather - Lavender Hand Sanitizer Wipes With Moisturizing Aloe 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

ETHYL ALCOHOL 65% v/v

Purpose

ANTIMICROBIAL

Uses

  • For hand sanitizing to decrease bacteria on the skin when water and soap are not available.Recommended for repeated use.

Warnings

For external use only. Flammable: keep away from fire or flame. When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water. Stop use and contact a doctor if irritation or redness persists for more than 72hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Remove wipeWet hands thoroughly with wipe and allow hands to dry without wiping.

Inactive Ingredients

Water, glycerin,lavandula angustifolia (lavender) oil, organic aloe barbadensis leaf extract, organic althaea officinalis (marshmallow) root extract, organic avena sativa (oat) kernel extract, organic camellia sinensis (white tea) leaf extract, organic chamomilla recutita (matricaria) flower extract, organic cucumis sativus (cucumber) fruit extract.

* Please review the disclaimer below.