drug facts

drug facts

SPL v1

SPL

SPL Set ID 35cb494e-82ab-4813-b486-552e2728a7fb

Route

topical

Published

Effective Date 2020-10-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (650 mg)

Inactive Ingredients

water polyethylene glycol 300 acrylates/vinyl isodecanoate crosspolymer (10000 mpa.s neutralized at 0.5%) glycerin isopropyl myristate isopropyl alcohol .alpha.-tocopherol acetate, dl- aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-10-06

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Medication Information

Warnings

For External use only

Flammable
Keep away from source of heat or fire.

Uses

For Personal hand hygiene to help the spread of bacteria and can be used in place of hand washing if soap and water are not available.

Purpose

Antiseptic

Directions

Adults only
For occasional and personal use
Rub thoroughly into hands for at least 30 seconds. Allow to dry

Other Information

Store at a temperature below 110⁰F (43⁰C)
May discolr certain fabrics or surfaces

Inactive Ingredients

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer

Description

Ethyl Alcohol 65%

Do Not Use

Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not Inhale.

Label Copy

Active Ingredients

Ethyl Alcohol 65%

Questions Or Comments ?

1-866-695-3030

When Using This Product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not Inhale.

Stop Use and Sak A Doctor

If irritation or redness develops and lasts

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Centre immedoately

Structured Label Content

Warnings

For External use only

Flammable
Keep away from source of heat or fire.

Uses

For Personal hand hygiene to help the spread of bacteria and can be used in place of hand washing if soap and water are not available.

Purpose

Antiseptic

Directions

Adults only
For occasional and personal use
Rub thoroughly into hands for at least 30 seconds. Allow to dry

Other Information (Other information)

Store at a temperature below 110⁰F (43⁰C)
May discolr certain fabrics or surfaces

Inactive Ingredients

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer

Do Not Use (Do not use)

Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not Inhale.

Label Copy (Label copy)

Active Ingredients

Ethyl Alcohol 65%

Questions Or Comments ? (Questions or comments ?)

1-866-695-3030

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not Inhale.

Stop Use and Sak A Doctor (Stop use and sak a doctor)

If irritation or redness develops and lasts

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 Centre immedoately

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": "POLYETHYLENE GLYCOL 300", "unii": "5655G9Y8AQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)", "unii": "2N8MDB79NA", "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": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For Personal hand hygiene to help the spread of bacteria and can be used in place of hand washing if soap and water are not available.", "Purpose": "Antiseptic", "Warnings": "For External use only Flammable Keep away from source of heat or fire.", "Directions": "Adults only For occasional and personal use Rub thoroughly into hands for at least 30 seconds. Allow to dry", "Do not use": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not Inhale.", "Other information": "Store at a temperature below 110 0 F (43 0 C) May discolr certain fabrics or surfaces", "Active Ingredients": "Ethyl Alcohol 65%", "Inactive Ingredients": "Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer", "Questions or comments ?": "1-866-695-3030", "When using this product": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not Inhale.", "Stop use and sak a doctor": "If irritation or redness develops and lasts", "Keep out of reach of children": "In case of accidental ingestion, get medical help or contact a Poison Control Centre immedoately"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:53.782488 · Updated: 2026-03-14T22:58:41.209834