Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a318857f-fa69-462d-9fed-b34199689ad3

Route

TOPICAL

Published

Effective Date 2018-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (650 mg)

Inactive Ingredients

Water Isopropyl Alcohol .alpha.-glucan Oligosaccharide Glycerin Aloe Vera Leaf Isopropyl Myristate Carbomer 934 .alpha.-tocopherol Acetate, Dl- Aminomethylpropanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-01-31

Description

Ethyl Alcohol 65%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses

to decrease bacteria on the skin.

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

Directions

put enough product in your palm to cover hands and rub hands together until dry
for children under 6, use lonly under adult supervision
not recommended for infants

Label Copy

Active Ingredient

Ethyl Alcohol 65%

Other Information

store at atemperature below 110°F (43°C)
may discolor some fabrics

Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

When Using This Product

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

Stop Use and Ask A Doctor If

irritation or redness develops
condition persists for more than 72 hours

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

Directions

put enough product in your palm to cover hands and rub hands together until dry
for children under 6, use lonly under adult supervision
not recommended for infants

Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Other Information (Other information)

store at atemperature below 110°F (43°C)
may discolor some fabrics

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or redness develops
condition persists for more than 72 hours

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-GLUCAN OLIGOSACCHARIDE", "unii": "S95658MI3W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to decrease bacteria on the skin.", "Purpose": "Antiseptic", "Warnings": "For external use only: hands Flammable. Keep away from fire or flame.", "Directions": "put enough product in your palm to cover hands and rub hands together until dry for children under 6, use lonly under adult supervision not recommended for infants", "Active ingredient": "Ethyl Alcohol 65%", "Other information": "store at atemperature below 110°F (43°C) may discolor some fabrics", "Inactive ingredients": "Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).", "When using this product": "keep out of eyes. In case of contact with eyes, flush thoroughly with water.", "Stop use and ask a doctor if": "irritation or redness develops condition persists for more than 72 hours", "Keep out of reach of children.": "In case of accidental ingestion, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:29.999242 · Updated: 2026-03-14T22:55:00.598631