5259 Hand Sanitizer

SPL v3

SPL

SPL Set ID 3923fe13-0e57-406a-afb9-3e9cef263dab

Route

TOPICAL

Published

Effective Date 2019-04-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (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 2019-04-25

Description

Active ingredient Ethyl alcohol 62%

Medication Information

Warnings and Precautions

Warnings:Flammable, keep away from fire or flame. For external use only.

Stop use and ask a doctor ifirritation and redness develop and persists for more than 72 hours.

Indications and Usage

For handwashing to decrease bacteria on the skin.

Dosage and Administration

Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

Description

Active ingredient Ethyl alcohol 62%

Section 42229-5

Made in China for Innovation Line Culver City, CA 90230

Section 44425-7

Store at room temperature 15° to 30°C (59° to 86°F).

Section 50565-1

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

Section 51727-6

Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Section 53413-1

Questions? Call 1-855-755 5346

NPN# 80062390 Citrus Scent

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Ethyl alcohol 62%

Packaging

Structured Label Content

Indications and Usage (34067-9)

For handwashing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

Warnings and Precautions (34071-1)

Warnings:Flammable, keep away from fire or flame. For external use only.

Stop use and ask a doctor ifirritation and redness develop and persists for more than 72 hours.

Section 42229-5 (42229-5)

Made in China for Innovation Line Culver City, CA 90230

Section 44425-7 (44425-7)

Store at room temperature 15° to 30°C (59° to 86°F).

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 51727-6 (51727-6)

Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Section 53413-1 (53413-1)

Questions? Call 1-855-755 5346

NPN# 80062390 Citrus Scent

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Ethyl alcohol 62%

Packaging

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": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For handwashing to decrease bacteria on the skin.", "34068-7": "Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.", "34071-1": "Warnings: Flammable, keep away from fire or flame. For external use only. Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.", "42229-5": "Made in China for Innovation Line Culver City, CA 90230", "44425-7": "Store at room temperature 15° to 30°C (59° to 86°F).", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.", "53413-1": "Questions? Call 1-855-755 5346 NPN# 80062390 Citrus Scent", "55105-1": "Purpose Antiseptic", "55106-9": "Active ingredient Ethyl alcohol 62%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:17.146435 · Updated: 2026-03-14T23:03:15.788850