Probiotic Hand Sanitizer
FDA Label NDC 81001-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Country Life Vitamins for the product Probiotic Hand Sanitizer (NDC 81001-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 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

Package Label.Principal Display Panel

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