Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a5eb9f4d-8ea5-78ed-e053-2a95a90ae35e

Route

TOPICAL

Published

Effective Date 2020-05-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Butylene Glycol 1,2-hexanediol Calendula Officinalis Flower Glycerin Water Melaleuca Alternifolia Leaf Cymbopogon Citratus Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-17

Description

alcohol

Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

Indications and Usage

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.

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

water, glycerin, cymbopogon citratus leaf oil, melaleuca alternifolia leaf oil, calendula officinalis flower extract, rosmarinus officinalis extract, butylene glycol, 1,2-hexanediol

Section 51945-4

Section 55105-1

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

Section 55106-9

alcohol

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

water, glycerin, cymbopogon citratus leaf oil, melaleuca alternifolia leaf oil, calendula officinalis flower extract, rosmarinus officinalis extract, butylene glycol, 1,2-hexanediol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

Section 55106-9 (55106-9)

alcohol

Advanced Ingredient Data

[{"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "MELALEUCA ALTERNIFOLIA LEAF", "unii": "G43C57162K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYMBOPOGON CITRATUS LEAF", "unii": "06JMS448M5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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.", "34068-7": "for external use only", "34071-1": "For external use only. Flammable, keep away from fire or flame. When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "water, glycerin, cymbopogon citratus leaf oil, melaleuca alternifolia leaf oil, calendula officinalis flower extract, rosmarinus officinalis extract, butylene glycol, 1,2-hexanediol", "55105-1": "hand sanitizer to help reduce bacteria that potentially can cause disease for use when soap and water are not available", "55106-9": "alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:37.151083 · Updated: 2026-03-14T22:56:51.376724