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SPL v1

SPL

SPL Set ID a7b2e95e-8bdd-d2dc-e053-2995a90aded6

Route

TOPICAL

Published

Effective Date 2020-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) .alpha.-tocopherol Acetate Aminomethylpropanol Denatonium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-06-10

Description

ACTIVE INGREDIENT Ethyl Alcohol 75%

Medication Information

Warnings and Precautions

WARNINGS

For external use only. Flammable. Keep away

from fire or flame. Avoid contact with broken skin.

Indications and Usage

USES

Decreases bacteria on hands.

Dosage and Administration

DIRECTIONS

Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised. Not recommended for infants.

Description

ACTIVE INGREDIENT Ethyl Alcohol 75%

Section 44425-7

OTHER INFORMATION

Do not store above 110°F. May discolor some fabrics.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9

Stop use and ask a doctor if irritation or rash develops.

Section 50570-1

Do not use in or near the eyes. In case of contact, flush thoroughly with water.

Section 51727-6

INACTIVE INGREDIENTS

Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol,

Denatonium benzoate, Fragrance (Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua)

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

ACTIVE INGREDIENT

Ethyl Alcohol 75%

Structured Label Content

Indications and Usage (34067-9)

USES

Decreases bacteria on hands.

Dosage and Administration (34068-7)

DIRECTIONS

Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised. Not recommended for infants.

Warnings and Precautions (34071-1)

WARNINGS

For external use only. Flammable. Keep away

from fire or flame. Avoid contact with broken skin.

Section 44425-7 (44425-7)

OTHER INFORMATION

Do not store above 110°F. May discolor some fabrics.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash develops.

Section 50570-1 (50570-1)

Do not use in or near the eyes. In case of contact, flush thoroughly with water.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol,

Denatonium benzoate, Fragrance (Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

Ethyl Alcohol 75%

Advanced Ingredient Data

[{"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USES Decreases bacteria on hands.", "34068-7": "DIRECTIONS Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised. Not recommended for infants.", "34071-1": "WARNINGS For external use only. Flammable. Keep away from fire or flame. Avoid contact with broken skin.", "44425-7": "OTHER INFORMATION Do not store above 110°F. May discolor some fabrics.", "50565-1": "Keep out of reach of children. If swallowed, get medical help.", "50566-9": "Stop use and ask a doctor if irritation or rash develops.", "50570-1": "Do not use in or near the eyes. In case of contact, flush thoroughly with water.", "51727-6": "INACTIVE INGREDIENTS Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Denatonium benzoate, Fragrance (Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua)", "55105-1": "Purpose Antiseptic", "55106-9": "ACTIVE INGREDIENT Ethyl Alcohol 75%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:51.861243 · Updated: 2026-03-14T22:57:08.393483