PROBIOTIC HAND SANITIZER 75 PERCENT ALCOHOL- alcohol gel

PROBIOTIC HAND SANITIZER by

Drug Labeling and Warnings

PROBIOTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Country Life Vitamins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 APPEARS 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.

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 ACID

TEA 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 ACID

TEA 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 ACID

TEA 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

BLOD ORANGE:  Illicium Verum (Anise) Fruit/Seed Oil, Ocimum Basilicum (Basil) Oil, Citrus Aurantium Bergamia Fruit Oil (Bergamot), Cananga Odorata Flower Oil (Ylang), Cymbopogon Nardum (Citronella) Oil, Pelargonium Graveolens Oil (Geranium), Citrus Paradisi (Grapefruit) Peel Oil, Litsea Cubeba Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Mentha Viridis (Spearmint) Leaf Oil, Citrus Reticulata (Tangerine) Peel Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROBIOTIC HAND SANITIZER  75 PERCENT ALCOHOL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81001-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
BASIL OIL (UNII: Z129UMU8LE)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
CITRONELLA OIL (UNII: QYO8Q067D0)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
GRAPEFRUIT OIL (UNII: YR377U58W9)
LITSEA OIL (UNII: 2XIW34BN6O)
ORANGE OIL (UNII: AKN3KSD11B)
SPEARMINT OIL (UNII: C3M81465G5)
TANGERINE (UNII: KH3E3096OO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81001-101-08	238 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020
2	NDC: 81001-101-02	50.28 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020
3	NDC: 81001-101-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/13/2020

Labeler - Country Life Vitamins (060345436)