83807-001 Sanitizer

SPL v1

SPL

SPL Set ID b9909c59-02e7-4d6c-aa2b-206f1ab4d02c

Route

TOPICAL

Published

Effective Date 2023-11-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Water Glycerin Propylene Glycol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Tocopheryl Glucoside Aminomethylpropanol Denatonium Benzoate Maltodextrin Aloe

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-14

Description

Active ingredient Ethyl Alcohol, 75% v/v

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

near the eyes, if happens, rinse thoroughly with water.

if you are allergic to any of the ingredients

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Indications and Usage

Uses

Kill germs and bacteria on skin to help reducing risk of infections

Dosage and Administration

Directions

Apply a dime sized amount to palm of hand. Rub santizer all over surface of hands and fingers. Allow hands to dry. Discard properly after use.

Description

Active ingredient Ethyl Alcohol, 75% v/v

Section 44425-7

Other information

Store at room temperature

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use in the eyes. If irritation or redness occurs, stop use.

Section 51727-6

Inactive ingredients

water, glycerin, propylene glycol, acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, fragrance, denatonium benzoate, tocopheryl acetate, aloe barbadensis leaf jiuce, maltodextrin

Section 51945-4

Section 55105-1

Purpose Antiseptic

Section 55106-9

Active ingredient

Ethyl Alcohol, 75% v/v

Structured Label Content

Indications and Usage (34067-9)

Uses

Kill germs and bacteria on skin to help reducing risk of infections

Dosage and Administration (34068-7)

Directions

Apply a dime sized amount to palm of hand. Rub santizer all over surface of hands and fingers. Allow hands to dry. Discard properly after use.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

near the eyes, if happens, rinse thoroughly with water.

if you are allergic to any of the ingredients

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Section 44425-7 (44425-7)

Other information

Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use in the eyes. If irritation or redness occurs, stop use.

Section 51727-6 (51727-6)

Inactive ingredients

water, glycerin, propylene glycol, acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, fragrance, denatonium benzoate, tocopheryl acetate, aloe barbadensis leaf jiuce, maltodextrin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Ethyl Alcohol, 75% v/v

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)", "unii": "8Z5ZAL5H3V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHERYL GLUCOSIDE", "unii": "9CKD1JE38R", "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": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE", "unii": "V5VD430YW9", "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 Kill germs and bacteria on skin to help reducing risk of infections", "34068-7": "Directions Apply a dime sized amount to palm of hand. Rub santizer all over surface of hands and fingers. Allow hands to dry. Discard properly after use.", "34071-1": "Warnings For external use only . Flammable, keep away from fire or flame . Do not use near the eyes, if happens, rinse thoroughly with water. if you are allergic to any of the ingredients Stop use and ask a doctor if irritation, excessive redness or rash develops.", "44425-7": "Other information Store at room temperature", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately. Do not use in the eyes. If irritation or redness occurs, stop use.", "51727-6": "Inactive ingredients water, glycerin, propylene glycol, acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, fragrance, denatonium benzoate, tocopheryl acetate, aloe barbadensis leaf jiuce, maltodextrin", "55105-1": "Purpose Antiseptic", "55106-9": "Active ingredient Ethyl Alcohol, 75% v/v"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:20.791841 · Updated: 2026-03-14T23:01:50.647319