40479e2f-b950-64ca-e054-00144ff88e88

SPL v1

SPL

SPL Set ID 40479e2f-b950-64ca-e054-00144ff88e88

Route

topical

Published

Effective Date 2016-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (62 mL)

Inactive Ingredients

water aloe vera leaf glycerin propylene glycol fd&c yellow no. 5 fd&c red no. 4

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2016-11-01

Description

Active Ingredient Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Active Ingredient

Active Ingredient

Ethyl Alcohol 62%

Indications and Usage

Uses

Decrease bacteria on hands

Dosage and Administration

Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly until dry.

Description

Active Ingredient Ethyl Alcohol 62%

Section 50565-1

Keep it out of children.

Section 50566-9

Stop use and ask a doctor if irritation or redness develops. If swallowed, get medical help or contact a doctor right away.

Section 51727-6

Inactive Ingredients

Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, FD&C Red No.4, FD&C Yellow No. 5

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Active Ingredient (55106-9)

Active Ingredient

Ethyl Alcohol 62%

Indications and Usage (34067-9)

Uses

Decrease bacteria on hands

Dosage and Administration (34068-7)

Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly until dry.

Section 50565-1 (50565-1)

Keep it out of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops. If swallowed, get medical help or contact a doctor right away.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, FD&C Red No.4, FD&C Yellow No. 5

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Decrease bacteria on hands", "34068-7": "Directions: Pump as needed into your palms to cover hands. Rub hands together briskly until dry.", "34071-1": "Warnings For external use only. Keep out of eyes. In case of contact with eyes, flush thoroughly with water.", "50565-1": "Keep it out of children.", "50566-9": "Stop use and ask a doctor if irritation or redness develops. If swallowed, get medical help or contact a doctor right away.", "51727-6": "Inactive Ingredients Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, FD&C Red No.4, FD&C Yellow No. 5", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredient Ethyl Alcohol 62%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:12.694881 · Updated: 2026-03-14T22:54:30.332332