NDC 81001-101 Probiotic Hand Sanitizer 75 Percent Alcohol

Alcohol

NDC Product Code 81001-101

NDC 81001-101-02

Package Description: 50.28 mL in 1 BOTTLE

NDC 81001-101-08

Package Description: 238 mL in 1 BOTTLE

NDC 81001-101-15

Package Description: 15 mL in 1 BOTTLE

NDC Product Information

Probiotic Hand Sanitizer 75 Percent Alcohol with NDC 81001-101 is a a human over the counter drug product labeled by Country Life Vitamins. The generic name of Probiotic Hand Sanitizer 75 Percent Alcohol is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Country Life Vitamins

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.

Probiotic Hand Sanitizer 75 Percent Alcohol 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.

  • WATER (UNII: 059QF0KO0R)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • KEFIRAN (UNII: 8L821V6V99)
  • THYME (UNII: CW657OBU4N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
  • EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N)
  • ISOEICOSANE (UNII: AR294KAG3T)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ANISE OIL (UNII: 6Y89129C8H)
  • MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • VANILLIN (UNII: CHI530446X)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Country Life Vitamins
Labeler Code: 81001
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: 11-13-2020 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.

Probiotic Hand Sanitizer 75 Percent Alcohol Product Label Images

Probiotic Hand Sanitizer 75 Percent Alcohol 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 75% (V/V)

Purpose

ANTISEPTIC

Uses

  • HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

Warnings

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.THIS PRODUCT IS INTENDED FOR EXTERNAL USE ONLY.STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEAS AND LASTS.DO NOT USE ON DAMAGED OR BROKEN SKIN.WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE EYES. IN CASE OF CONTACT, RINSE THOROUGHLY WITH WATER.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER BRISKLY UNTIL DRY (APPROXIMATELY 30 SECONDS).CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information

  • STORE BELOW 110°F (43°C)MAY DISCOLOR CERTAIN FABRICS

Inactive Ingredients

TEA TREE & LEMONGRASS: WATER (AQUA), HYDROXYPROPYLCELLULOSE, CYMBOPOGON SCHOENANTHUS (LEMONGRASS) OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, THYMUS VULGARIS (THYME) LEAF EXTRACT, GLYCERIN, SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), ISOEICOSANE, CITRIC ACIDTEA TREE OIL: WATER (AQUA), HYDROXYPROPYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), THYMUS VULGARIS (THYME) LEAF EXTRACT, GLYCERIN, ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), ISOEICOSANE, CITRIC ACIDTEA TREE & LAVENDER: WATER (AQUA), HYDROXYPROPYLCELLULOSE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), MELALEUCA ALTERNIFOLIA (TEA
TREE) LEAF OIL, GLYCERIN, ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), THYMUS VULGARIS (THYME) LEAF EXTRACT, SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), NATURAL FRAGRANCE (PARFUM), ISOEICOSANE, CITRIC ACIDTEA TREE & PEPPERMINT: WATER (AQUA), HYDROXYPROPYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), ILLICIUM VERUM (ANISE) FRUIT/SEED OIL, MENTHA ARVENSE LEAF OIL (MINT), EUCALYPTUS GLOBULUS LEAF OIL, THYMUS VULGARIS (THYME) LEAF EXTRACT, GLYCERIN, VANILLIN, SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), TRIETHYL CITRATE, SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), ISOEICOSANE, CITRIC ACID

* Please review the disclaimer below.