43473-075 Health Beyond Hand Sanitizer

SPL v1

SPL

SPL Set ID e5746be7-e9dc-42a6-a3d0-b386427caec5

Route

TOPICAL

Published

Effective Date 2025-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Glycerin Propylene Glycol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) .alpha.-tocopherol Acetate, D- Denatonium Benzoate Aloe Vera Leaf Aminomethyl Propanediol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-27

Description

Active ingredient Alcohol 62% v/v

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable: keep away from heat or flame

Do not use in the eyes

Use with caution if allergic to alcohol

Indications and Usage

Uses

For hand sanitizing to decrease bacteria on skin without soap and water

Dosage and Administration

Directions:

Put enough product on your palm to cover hands and briskly rub hands until dry

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision.

Description

Active ingredient Alcohol 62% v/v

Section 44425-7

Other information

Do not store above 105 F
May discolor some fabrics
Harmful to wood finishes and plastics

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Denatonium Benzoate, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua).

Section 51945-4

Section 55105-1

Purpose Antiseptic

Section 55106-9

Active ingredient

Alcohol 62% v/v

Structured Label Content

Indications and Usage (34067-9)

Uses

For hand sanitizing to decrease bacteria on skin without soap and water

Dosage and Administration (34068-7)

Directions:

Put enough product on your palm to cover hands and briskly rub hands until dry

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable: keep away from heat or flame

Do not use in the eyes

Use with caution if allergic to alcohol

Section 44425-7 (44425-7)

Other information

Do not store above 105 F
May discolor some fabrics
Harmful to wood finishes and plastics

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Denatonium Benzoate, Fragrance, Glycerin, 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

Alcohol 62% 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": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYL PROPANEDIOL", "unii": "CZ7BU4QZJZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For hand sanitizing to decrease bacteria on skin without soap and water", "34068-7": "Directions: Put enough product on your palm to cover hands and briskly rub hands until dry Wet hands thoroughly with product and allow to dry without wiping For children under 6, use only under adult supervision.", "34071-1": "Warnings For external use only. Flammable: keep away from heat or flame Do not use in the eyes Use with caution if allergic to alcohol", "44425-7": "Other information Do not store above 105 F May discolor some fabrics Harmful to wood finishes and plastics", "50565-1": "Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Denatonium Benzoate, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua).", "55105-1": "Purpose Antiseptic", "55106-9": "Active ingredient Alcohol 62% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.423571 · Updated: 2026-03-14T23:08:08.103878