a7b2e95e-8bdd-d2dc-e053-2995a90aded6

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.

Active Ingredient

ACTIVE INGREDIENT

Ethyl Alcohol 75%

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

Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS

For external use only. Flammable. Keep away

from fire or flame. Avoid contact with broken skin.

Active Ingredient (55106-9)

ACTIVE INGREDIENT

Ethyl Alcohol 75%

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.

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

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