Antibacterial Hand Sanitizer

SPL v2

SPL

SPL Set ID ce2d6c41-9423-45bd-8cbf-6749fdbb2c9f

Route

TOPICAL

Published

Effective Date 2020-03-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.62 mL)

Inactive Ingredients

Carbomer Homopolymer, Unspecified Type Glycerin Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-20

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

For hand washing to decrease bacteria on the skin.

Section 42229-5

Flammable. Keep away from heat and flame.

Warnings

For external use only.

Directions

Wet hands thoroughly with a product and allow to dry without wiping.

Other Information

Store under 105 F. ^o

Package Labeling:

Active Ingredients

Ethyl Alcohol 62%

Inactive Ingredients

Water, Polyquaternium-10, Propylene Glycol, Glycerin, Polyaminopropyl Biguanide, PEG-40 Hydrogenated Castor Oil, Fragrance, Tromethamine

When Using This Product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop Use and Ask A Doctor If

if skin irritation develops.

Keep Out of Reach of Children.

If swallowed, get medical help or call a Poison Control Center right away.

Structured Label Content

Uses

For hand washing to decrease bacteria on the skin.

Section 42229-5 (42229-5)

Flammable. Keep away from heat and flame.

Purpose

Antiseptic

Warnings

For external use only.

Directions

Wet hands thoroughly with a product and allow to dry without wiping.

Other Information

Store under 105 F. ^o

Package Labeling:

Active Ingredients

Ethyl Alcohol 62%

Inactive Ingredients

Water, Polyquaternium-10, Propylene Glycol, Glycerin, Polyaminopropyl Biguanide, PEG-40 Hydrogenated Castor Oil, Fragrance, Tromethamine

When Using This Product (When using this product)

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

if skin irritation develops.

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

If swallowed, get medical help or call a Poison Control Center right away.

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": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.62", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin.", "42229-5": "Flammable. Keep away from heat and flame.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Wet hands thoroughly with a product and allow to dry without wiping.", "Other Information": "Store under 105 F. o", "Active Ingredients": "Ethyl Alcohol 62%", "Inactive Ingredients": "Water, Polyquaternium-10, Propylene Glycol, Glycerin, Polyaminopropyl Biguanide, PEG-40 Hydrogenated Castor Oil, Fragrance, Tromethamine", "When using this product": "Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.", "Stop use and ask a doctor if": "if skin irritation develops.", "Keep out of reach of children.": "If swallowed, get medical help or call a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:17.347660 · Updated: 2026-03-14T23:01:42.949822