hand sanitizer

SPL v2

SPL

SPL Set ID a3d74dc3-fb4b-ddc0-e053-2a95a90a2b90

Route

topical

Published

Effective Date 2020-04-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

carbomer homopolymer, unspecified type glycerin alpha-tocopherol acetate water trolamine propylene glycol aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-21

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 75% v/v. Purpose: Antiseptic

Medication Information

Warnings

Flammable. Keep away from heat or flame. For external use only.

Purpose

Antiseptic, Hand Sanitizer

Directions

Spread on both hands, rub it, let dry.

Inactive Ingredients

Aloe barbadensis gel, carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

Antiseptic Hand Sanitizer

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 redness or irritation develop and persist for more than 72 hours.

Section 50567-7

Avoid contact with eyes. In case of contact flush eyes with water.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

236 mL NDC: 75729-001-01

500 mL NDC: 75729-001-02

3785 mL NDC: 75729-001-03

Structured Label Content

Warnings

Flammable. Keep away from heat or flame. For external use only.

Purpose

Antiseptic, Hand Sanitizer

Directions

Spread on both hands, rub it, let dry.

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis gel, carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water

Use

Antiseptic Hand Sanitizer

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 redness or irritation develop and persist for more than 72 hours.

Section 50567-7 (50567-7)

Avoid contact with eyes. In case of contact flush eyes with water.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

236 mL NDC: 75729-001-01

500 mL NDC: 75729-001-02

3785 mL NDC: 75729-001-03

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic Hand Sanitizer", "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 redness or irritation develop and persist for more than 72 hours.", "50567-7": "Avoid contact with eyes. In case of contact flush eyes with water.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "Flammable. Keep away from heat or flame. For external use only.", "Directions": "Spread on both hands, rub it, let dry.", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Aloe barbadensis gel, carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water", "Package Label - Principal Display Panel": "236 mL NDC: 75729-001-01 500 mL NDC: 75729-001-02 3785 mL NDC: 75729-001-03"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:29.676842 · Updated: 2026-03-14T22:56:40.798179