drug facts

drug facts

SPL v1

SPL

SPL Set ID 7f068b75-409b-4fb1-b455-8358322563ec

Route

topical

Published

Effective Date 2020-03-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (650 mg)

Inactive Ingredients

water isopropyl alcohol glycerin isopropyl myristate aloe vera leaf .alpha.-tocopherol acetate, dl- carbomer 934 aminomethylpropanol

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-13

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Medication Information

Warnings

For external use only
Flammable
Keep away from source of heat or fire.

Uses

to help reduce bacteria on the skin.

Purpose

Antiseptic

Directions

wet hands thoroughly and rub together until dry.

Other Information

store at a temperature below 110°F (43°C)

Inactive Ingredients

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

Description

Ethyl Alcohol 65%

Active Ingredient

Ethyl Alcohol 65%

Label Copy 2 Fl Oz

Label Copy 12 Fl Oz

Questions Or Comments?

1-800-934-1204

When Using This Product

avoid contact with eyes. If contact occurs, rinse with water.

Keep Out of Reach of Children.

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

Stop Using This Product and Ask Doctor If

irritation or redness develops and lasts.

Structured Label Content

Warnings

For external use only
Flammable
Keep away from source of heat or fire.

Uses

to help reduce bacteria on the skin.

Purpose

Antiseptic

Directions

wet hands thoroughly and rub together until dry.

Other Information (Other information)

store at a temperature below 110°F (43°C)

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Label Copy 2 Fl Oz (Label Copy 2 fl oz)

Label Copy 12 Fl Oz (Label Copy 12 fl oz)

Questions Or Comments? (Questions or comments?)

1-800-934-1204

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse with water.

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 immediately.

Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if )

irritation or redness develops and lasts.

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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to help reduce bacteria on the skin.", "Purpose": "Antiseptic", "Warnings": "For external use only Flammable Keep away from source of heat or fire.", "Directions": "wet hands thoroughly and rub together until dry.", "Active ingredient": "Ethyl Alcohol 65%", "Other information": "store at a temperature below 110°F (43°C)", "Inactive ingredients": "Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).", "Questions or comments?": "1-800-934-1204", "When using this product": "avoid contact with eyes. If contact occurs, rinse with water.", "Keep out of reach of children.": "In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.", "Stop using this product and ask doctor if ": "irritation or redness develops and lasts."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:04.271223 · Updated: 2026-03-14T22:55:59.360416