Hand Sanitizer

SPL v1

SPL

SPL Set ID a38264ba-2b94-4dcb-e053-2a95a90a7c26

Route

TOPICAL

Published

Effective Date 2020-04-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (65 mL)

Inactive Ingredients

Carbomer Interpolymer Type A (55000 Cps) Hydrolyzed Jojoba Esters (acid Form) Trolamine Aloe Vera Leaf Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-17

Description

Alcohol 75% v/v. Purpose: Antiseptic

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame. Do not use in children less than 2 months of age on open skin wounds.

Indications and Usage

Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use. For use when soap and water are not available.

Dosage and Administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.

Description

Alcohol 75% v/v. Purpose: Antiseptic

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

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

Section 51727-6

Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine ,Aloe Barbadensis Leaf Juice Powder, Citric Acid

Section 51945-4

55450-004-01 500mL

Section 55105-1

Antiseptic, Hand Sanitizer

Section 55106-9

Alcohol 75% v/v. Purpose: Antiseptic

Section 60561-8

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).

This product can effectively kill 99.99% Escherichia coli, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa under experimental conditions. The results are for reference only.

Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use. For use when soap and water are not available.

Dosage and Administration (34068-7)

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame. Do not use in children less than 2 months of age on open skin wounds.

Section 50565-1 (50565-1)

keep out of reach of children. If sallowed, 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 rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine ,Aloe Barbadensis Leaf Juice Powder, Citric Acid

Section 51945-4 (51945-4)

55450-004-01 500mL

Section 55105-1 (55105-1)

Antiseptic, Hand Sanitizer

Section 55106-9 (55106-9)

Alcohol 75% v/v. Purpose: Antiseptic

Section 60561-8 (60561-8)

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).

This product can effectively kill 99.99% Escherichia coli, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa under experimental conditions. The results are for reference only.

Advanced Ingredient Data

[{"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROLYZED JOJOBA ESTERS (ACID FORM)", "unii": "UDR641JW8W", "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": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use. For use when soap and water are not available.", "34068-7": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.", "34071-1": "For external use only. Flammable. Keep away from heat or flame. Do not use in children less than 2 months of age on open skin wounds.", "50565-1": "keep out of reach of children. If sallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50567-7": "Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.", "51727-6": "Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine ,Aloe Barbadensis Leaf Juice Powder, Citric Acid", "51945-4": "55450-004-01 500mL", "55105-1": "Antiseptic, Hand Sanitizer", "55106-9": "Alcohol 75% v/v. Purpose: Antiseptic", "60561-8": "Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F). This product can effectively kill 99.99% Escherichia coli, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa under experimental conditions. The results are for reference only."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:15.519565 · Updated: 2026-03-14T22:56:15.235167