Hand Sanitizer

SPL v1

SPL

SPL Set ID a9fa6ebf-e44d-39d8-e053-2995a90aacba

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Aloe Vera Leaf Propylene Glycol Water Glycerin Triethanolamine Dodecylbenzenesulfonate Carbomer 934

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62% v/v

Use

For handwashing to decrease bacteria on the skin.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

Section 50567-7

For external use only. Flammable. Keep away from fire and flame.

Warnings

For external use only. Flammable. Keep away from fire and flame.

Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

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

Directions

Wet hands thoroughly with product. briskly rub hands together until dry.

Supervise children under 6 years in the use of this product.

Do Not Use

Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

Other Information

Store at 20°C to 25°C (68°to 77°F )

May discolor certain fabrics.

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Aloe Barbadensis Leaf Juice.

Package Label Principal Display Panel

Structured Label Content

Use

For handwashing to decrease bacteria on the skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

Section 50567-7 (50567-7)

For external use only. Flammable. Keep away from fire and flame.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from fire and flame.

Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

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

Directions

Wet hands thoroughly with product. briskly rub hands together until dry.

Supervise children under 6 years in the use of this product.

Do Not Use (Do not use)

Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

Other Information (Other information)

Store at 20°C to 25°C (68°to 77°F )

May discolor certain fabrics.

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Aloe Barbadensis Leaf Juice.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE DODECYLBENZENESULFONATE", "unii": "8HM7ZD48HN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For handwashing to decrease bacteria on the skin.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.", "50567-7": "For external use only. Flammable. Keep away from fire and flame.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from fire and flame. Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Wet hands thoroughly with product. briskly rub hands together until dry. Supervise children under 6 years in the use of this product.", "Do not use": "Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.", "Other information": "Store at 20°C to 25°C (68°to 77°F ) May discolor certain fabrics.", "Active Ingredient(s)": "Ethyl Alcohol 62% v/v", "Inactive ingredients": "Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Aloe Barbadensis Leaf Juice.", "Package Label - Principal Display Panel": "."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:09.157388 · Updated: 2026-03-14T22:57:34.491747