NDC 79655-606 Swedish Dream Sea Salt Hand Sanitizer

Ethyl Alcohol Formulation

NDC Product Code 79655-606

NDC 79655-606-01

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Swedish Dream Sea Salt Hand Sanitizer with NDC 79655-606 is a a human over the counter drug product labeled by Kala Corporation. The generic name of Swedish Dream Sea Salt Hand Sanitizer is ethyl alcohol formulation. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Kala Corporation

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.

Swedish Dream Sea Salt 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 38.35 mL/59mL

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.

  • 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • WATER (UNII: 059QF0KO0R)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • LINALYL ACETATE (UNII: 5K47SSQ51G)
  • ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
  • .ALPHA.-AMYLCINNAMALDEHYDE DIMETHYL ACETAL (UNII: M2X8F8W2U8)
  • METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)
  • 8-(N-INDOLYL)-2,6-DIMETHYL-7-OCTEN-2-OL (UNII: 00NG926C95)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)
  • 2,6,10-TRIMETHYL-9-UNDECENAL (UNII: JNM5JFE28J)
  • 2-METHYLUNDECANAL (UNII: S94QNS2VY5)
  • 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • .ALPHA.-TERPINEOL (UNII: 21334LVV8W)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • ISOAMYL SALICYLATE (UNII: M25E4ZMR0N)
  • 3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH)
  • METHYL 2-NONYNOATE (UNII: 8RN66UR57V)

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: Kala Corporation
Labeler Code: 79655
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: 07-08-2020 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.

Swedish Dream Sea Salt 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

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

Sanitizer to help reduce bacteria on skin. For use when soap and water not available.

Warnings

For external use only. Keep away from heat or flame.

When Using This Product

Keep out of eyes. In case of contact, flush thoroughly with water.

Keep Out Of Reach Of Children

If swallowed get medical help or contact a poison control center right away.

Directions:

Apply on hands and rub until dry.

Other Information

Store between 15-30C(59-86F) - Avoid freezing and excess heat over 40C(104F)

Inactive Ingredients

Deionized Water, Glycerine, Sea Salt Essence (Fragrance Oil)

* Please review the disclaimer below.