NDC 78353-726 Soh Hand Sanitizer

Alcohol

NDC Product Code 78353-726

NDC 78353-726-34

Package Description: 100 mL in 1 BOTTLE

NDC 78353-726-35

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Soh Hand Sanitizer with NDC 78353-726 is a a human over the counter drug product labeled by The Scent Of Home Pty Ltd. The generic name of Soh Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: The Scent Of Home Pty Ltd

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.

Soh 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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

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: The Scent Of Home Pty Ltd
Labeler Code: 78353
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: 05-26-2020 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.

Soh Hand Sanitizer Product Label Images

Soh 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

Soh Fig Tree Hand Sanitiser

This luxury hand sanitiser is formulated with 75% alcohol together with Vitamin E, Aloe Leaf Juice and our Fig Tree parfum. Created to sanitise your hands, rid them of germs and leave your hands feeling fresh, hydrated and clean.Hand hygiene and the health of our hands is routinely needed to keep our bodies free from germs. The added benefit of our Fig Tree fragrance will make you feel invigorated and luxurious and confident of clean hands. The added element of Vitamin E and Aloe Barbadenis juice will keep your hands soft and moisturised.Apply 1 pump on the palm of your hands. Massage into the back of your hands fingertips until dry. Repeat when necessary.For external use only. Avoid contact with eyes.If eye contact occurs immediately flush with water. To ensure skin compatibility test product on a small patch of skin. Store out of reach of Children,If skin irritation occurs discontinue and seek medical advice. Do not use on extremely damaged skin. Contains 75% Alcohol v/v.
Made in AustraliaIngredients: Alcohol (75%), aqua (water), parfum ( fragrance), acrylates/C10-30, alkylacrylate, crosspolymer, natural vitamin E (tocopherol), aminomethylpropanol, coumarin, linalool, citral, methyl ionene, mixed isomers, aloe barbadensis leaf juice, glycerin.

Active Ingredient(S)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do Not Use

  • In children less than 2 months of ageon open skin wounds

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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Place enough product on 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 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Aqua (water), parfum ( fragrance), acrylates/C10-30 alkyl acrylate crosspolymer, natural vitamin E (tocopherol), aminomethylpropanol, coumarin, linalool, citral, methyl ionene, mixed isomers, aloe barbadensis leaf juice, glycerin.

500Ml Hand Sanitiser

500ml NDC:78353-726-35

100Ml Hand Sanitiser

100ml NDC: 78353-726-34

* Please review the disclaimer below.