Hand Sanitizer

SPL v4

SPL

SPL Set ID 2eb7aa23-747c-4b05-bb82-493c2dfb1cfd

Route

TOPICAL

Published

Effective Date 2020-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Carbomer Homopolymer, Unspecified Type Trolamine Aloe Vera Leaf Glycerin Propylene Glycol .alpha.-tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-02

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Warnings For external use only

Flammable Keep away from fire or flame

Keep out of eyes In case of eye contact, immediately flush with water and get medical help.

Indications and Usage

Use Decreases bacteria on hands

Purpose

Antiseptic

Dosage and Administration

Directions Squeeze onto hands and rub hands together briskly until dry.

Do Not Store Above 110°F

Non-staining, may discolor certain fabrics.

Description

Ethyl Alcohol 62%

Section 42229-5

Made in China.

http://ps.ppa.org/hsan

Packaging

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Inactive Ingredients

Deionized Water, Carbomer, Triethanolamine, Aloe Barbadensis Gel, Fragrance Glycerin, Propylene Glycol, Vitamin E.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Indications and Usage (34067-9)

Use Decreases bacteria on hands

Dosage and Administration (34068-7)

Directions Squeeze onto hands and rub hands together briskly until dry.

Do Not Store Above 110°F

Non-staining, may discolor certain fabrics.

Warnings and Precautions (34071-1)

Warnings For external use only

Flammable Keep away from fire or flame

Keep out of eyes In case of eye contact, immediately flush with water and get medical help.

Section 42229-5 (42229-5)

Made in China.

http://ps.ppa.org/hsan

Purpose

Antiseptic

Packaging

Drug Facts (DRUG FACTS)

Active Ingredient

Ethyl Alcohol 62%

Inactive Ingredients

Deionized Water, Carbomer, Triethanolamine, Aloe Barbadensis Gel, Fragrance Glycerin, Propylene Glycol, Vitamin E.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "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": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use Decreases bacteria on hands", "34068-7": "Directions Squeeze onto hands and rub hands together briskly until dry. Do Not Store Above 110°F Non-staining, may discolor certain fabrics.", "34071-1": "Warnings For external use only Flammable Keep away from fire or flame Keep out of eyes In case of eye contact, immediately flush with water and get medical help.", "42229-5": "Made in China. http://ps.ppa.org/hsan", "Purpose": "Antiseptic", "Active Ingredient": "Ethyl Alcohol 62%", "Inactive Ingredients": "Deionized Water, Carbomer, Triethanolamine, Aloe Barbadensis Gel, Fragrance Glycerin, Propylene Glycol, Vitamin E.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:21.164596 · Updated: 2026-03-14T23:00:44.685211