Antibacterial Hand Sanitizer Gel

SPL v1

SPL

SPL Set ID 202e5c15-8749-0a76-e063-6294a90a2720

Route

TOPICAL

Published

Effective Date 2024-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Fragrance 13576 .alpha.-tocopherol Acetate Butylene Glycol Aloe Vera Leaf Water Carbomer 940 Trolamine Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-30

Description

Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 62%

Uses

For hand Sanitizing

Section 44425-7

Other information

Do not store above 105 ^oF.
May discolor some fabrics.

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if skin irritation develops.

Section 50567-7

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.

Section 51945-4

Warnings

For external use only- hands.

Flammable. Keep away from heat and flame.

Directions

Wet hands throughly with product and allow to dry without wiping.
For children under 6 age use only under adult supervision.
Not recommended for infants.

Active Ingredients

Alcohol 62%

Inactive Ingredients

Aqua, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate.

Structured Label Content

Uses

For hand Sanitizing

Section 44425-7 (44425-7)

Other information

Do not store above 105 ^oF.
May discolor some fabrics.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if skin irritation develops.

Section 50567-7 (50567-7)

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.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only- hands.

Flammable. Keep away from heat and flame.

Directions

Wet hands throughly with product and allow to dry without wiping.
For children under 6 age use only under adult supervision.
Not recommended for infants.

Active Ingredients

Alcohol 62%

Inactive Ingredients

Aqua, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate.

Advanced Ingredient Data

[{"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand Sanitizing", "44425-7": "Other information Do not store above 105 o F. May discolor some fabrics.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "50566-9": "Stop use and ask doctor if skin irritation develops.", "50567-7": "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.", "Purpose": "Antiseptic", "Warnings": "For external use only- hands. Flammable. Keep away from heat and flame.", "Directions": "Wet hands throughly with product and allow to dry without wiping. For children under 6 age use only under adult supervision. Not recommended for infants.", "Active Ingredients": "Alcohol 62%", "Inactive Ingredients": "Aqua, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:26.546975 · Updated: 2026-03-14T23:03:31.233369