Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a1f5c917-9b5c-984f-e053-2a95a90a096c

Route

TOPICAL

Published

Effective Date 2020-03-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (75 g)

Inactive Ingredients

Glycerin Butylene Glycol Water .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-21

Description

ethyl 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

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dosage and Administration

for external use only

Description

ethyl alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Glycerin, tocopheryl acetate, etc.

Section 51945-4

Section 55105-1

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

Section 55106-9

ethyl alcohol

Structured Label Content

Indications and Usage (34067-9)

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

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, tocopheryl acetate, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

Section 55106-9 (55106-9)

ethyl alcohol

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry. Supervise children in the use of this product.", "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, tocopheryl acetate, etc.", "55105-1": "Antiseptic instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease instant hand antiseptic to decrease bacteria on the skin recommended for repeated use hand sanitizer to help reduce bacteria on the skin", "55106-9": "ethyl alcohol"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:05.902628 · Updated: 2026-03-14T22:56:00.983918