NDC 80123-002 Yankee Candle Hand Sanitizer With Moisturizer Lemon Lavender

Alcohol

NDC Product Code 80123-002

NDC 80123-002-01

Package Description: 118.3 mL in 1 BOTTLE

NDC 80123-002-02

Package Description: 3 BOTTLE in 1 PACKAGE > 118.3 mL in 1 BOTTLE

NDC 80123-002-03

Package Description: 236.6 mL in 1 BOTTLE

NDC 80123-002-04

Package Description: 2 BOTTLE in 1 PACKAGE > 236.6 mL in 1 BOTTLE

NDC Product Information

Yankee Candle Hand Sanitizer With Moisturizer Lemon Lavender with NDC 80123-002 is a a human over the counter drug product labeled by The Yankee Candle Company Inc. The generic name of Yankee Candle Hand Sanitizer With Moisturizer Lemon Lavender is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: The Yankee Candle Company Inc

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.

Yankee Candle Hand Sanitizer With Moisturizer Lemon Lavender 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 62.5 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.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

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 Yankee Candle Company Inc
Labeler Code: 80123
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: 10-26-2020 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.

Yankee Candle Hand Sanitizer With Moisturizer Lemon Lavender Product Label Images

Yankee Candle Hand Sanitizer With Moisturizer Lemon Lavender 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

Drug Facts

DISTRIBUTED BY YANKEE CANDLE, INC.16 YANKEE CANDLE WAY, SOUTH DEERFIELD, MA 01373 USA

Active Ingredients

Ethyl Alcohol 62.5%

Purpose

Antiseptic Cleanser

Use

To help reduce bacteria on hands.

Warnings

For external use only.Flammable, keep away from fire, flame or sparks.

Otc - Do Not Use

Do not use on damaged or broken skin | in or near eyes, ears or mouth | on children less than 2 months of age.

Otc - When Using

When using this product if in the eyes rinse thoroughly with water | discontinue use if irritation and/or redness develops.

Otc - Stop Use

Stop use and ask doctor if irritation or rash appears on the skin and persists for 72 hours.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply product onto hands, spread thoroughly and rub dry.Children under 6 years of age should be supervised by an adult to avoid swallowing.

Other Information

  • Store between 59-86F (15-30C)Avoid freezing and excessive heat above 104F (40C)May discolor certain fabrics or surfacesHarmful to wood finishes and plastics

Inactive Ingredients

Aqua (Water), Propylene Glycol, Dimethicone PEG-7 Isostearate, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Denatonium Benzoate, Tert Butyl Alcohol, 2-Amino-2-Methyl-1-Propanol, 2-Methylamino-2-Methyl-1-Propoanol, Tocopherol Acetate (Vitamin E), fragrance.

Questions?

Call 877-803-6890

* Please review the disclaimer below.