83502-002 Update

SPL v2

SPL

SPL Set ID fcbad83b-b8aa-a780-e053-6294a90a58ab

Route

TOPICAL

Published

Effective Date 2023-05-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Trolamine Allyl Methacrylate/glycol Dimethacrylate Crosspolymer Artemisia Annua Leaf Aloe Vera Leaf Glycerin Carbomer 1342 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-05-27

Description

Ethyl Alcohol 75%

Purpose

For hand sanitizing to decrease bacteria on the skin

Medication Information

Purpose

For hand sanitizing to decrease bacteria on the skin

Description

Ethyl Alcohol 75%

Use

To decrease bacteria on the skin

Stop Use

if irritation or rashappears and lasts

Warnings

For external use only

Flammable, Keep away from fire or flame

Ask Doctor

if irritation or rashappears and lasts

Directions

Squeeze small amount in your palm and brisklyRob hands together briskly until dry.

Do Not Use

in or near the eyes in case of contact, rinse eyes thoroughly with water

When Using

Pay attention to the method of use. do not touch eyes

Active Ingredient

Ethyl Alcohol 75%

Inactive Ingredients

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl AcrylateCrosspolymer,Triethanolamine, Artemisia Annua Extract, AloeBarbadensis Leaf Extract, Fragrance(Parfum)

Principal Display Panel

Keep Oot of Reach of Children

lf swallowed, getmedical help or contact a Poison Control Center right

Structured Label Content

Use

To decrease bacteria on the skin

Purpose

For hand sanitizing to decrease bacteria on the skin

Stop Use

if irritation or rashappears and lasts

Warnings

For external use only

Flammable, Keep away from fire or flame

Ask Doctor

if irritation or rashappears and lasts

Directions

Squeeze small amount in your palm and brisklyRob hands together briskly until dry.

Do Not Use (Do not use)

in or near the eyes in case of contact, rinse eyes thoroughly with water

When Using

Pay attention to the method of use. do not touch eyes

Active Ingredient

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl AcrylateCrosspolymer,Triethanolamine, Artemisia Annua Extract, AloeBarbadensis Leaf Extract, Fragrance(Parfum)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

lf swallowed, getmedical help or contact a Poison Control Center right

Advanced Ingredient Data

[{"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER", "unii": "B9J55EA6QX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARTEMISIA ANNUA LEAF", "unii": "E4M09UY5BL", "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": "CARBOMER 1342", "unii": "809Y72KV36", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "To decrease bacteria on the skin", "Purpose": "For hand sanitizing to decrease bacteria on the skin", "Stop Use": "if irritation or rashappears and lasts", "Warnings": "For external use only Flammable, Keep away from fire or flame", "Ask Doctor": "if irritation or rashappears and lasts", "Directions": "Squeeze small amount in your palm and brisklyRob hands together briskly until dry.", "Do not use": "in or near the eyes in case of contact, rinse eyes thoroughly with water", "When Using": "Pay attention to the method of use. do not touch eyes", "Active Ingredient": "Ethyl Alcohol 75%", "Inactive ingredients": "Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl AcrylateCrosspolymer,Triethanolamine, Artemisia Annua Extract, AloeBarbadensis Leaf Extract, Fragrance(Parfum)", "Keep Oot Of Reach Of Children": "lf swallowed, getmedical help or contact a Poison Control Center right"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.332508 · Updated: 2026-03-14T23:06:45.911086