Antibacterial Hand Sanitizer

SPL v1

SPL

SPL Set ID 6a2ec96d-1ba5-4cad-9f6d-e5c7848511d6

Route

TOPICAL

Published

Effective Date 2020-05-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Glycerin Propylene Glycol Carbomer Homopolymer, Unspecified Type Trolamine Aloe Vera Leaf .alpha.-tocopherol Acetate Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-30

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

• To help reduce bacteria on the skin.

Section 42229-5

KILLS GERMS WITHOUT WATER

Effective at eliminating over 99.99% of many common harmful germs and bacteria.

Distributed by:Royal Deluxe Accessories,LLC

Made in China / Fabrique'en Chine / Hecho en China

Section 50565-1

Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Warnings

For external use only. •Flammable. Keep away from fire or flame.

When using this product • avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if skin irritation or redness develops.

Packaging

Directions

• put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision.

• not recommended for infants.

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Other Information:

store at a temperature below 110°F.(43°C).
may discolor some fabrics.

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), FD&C Yellow No.5 (Tartrazine), FD&C Blue No.1.

Structured Label Content

Uses

• To help reduce bacteria on the skin.

Section 42229-5 (42229-5)

KILLS GERMS WITHOUT WATER

Effective at eliminating over 99.99% of many common harmful germs and bacteria.

Distributed by:Royal Deluxe Accessories,LLC

Made in China / Fabrique'en Chine / Hecho en China

Section 50565-1 (50565-1)

Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Purpose

Antiseptic

Warnings

For external use only. •Flammable. Keep away from fire or flame.

When using this product • avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if skin irritation or redness develops.

Packaging

Directions

• put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision.

• not recommended for infants.

Drug Facts

Active Ingredient (Active ingredient)

Ethyl Alcohol 62%

Other Information: (Other information:)

store at a temperature below 110°F.(43°C).
may discolor some fabrics.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), FD&C Yellow No.5 (Tartrazine), FD&C Blue No.1.

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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses ": "• To help reduce bacteria on the skin.", "42229-5": "KILLS GERMS WITHOUT WATER Effective at eliminating over 99.99% of many common harmful germs and bacteria. Distributed by:Royal Deluxe Accessories,LLC Made in China / Fabrique'en Chine / Hecho en China", "50565-1": "Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.", "Purpose": "Antiseptic", "Warnings": "For external use only. •Flammable. Keep away from fire or flame. When using this product • avoid contact with eyes. If contact occurs, rinse with water. Stop use and ask a doctor if skin irritation or redness develops.", "Directions": "• put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision. • not recommended for infants.", "Active ingredient": "Ethyl Alcohol 62%", "Other information:": "store at a temperature below 110°F.(43°C). may discolor some fabrics.", "Inactive ingredients": "Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), FD&C Yellow No.5 (Tartrazine), FD&C Blue No.1."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:27.906512 · Updated: 2026-03-14T22:56:37.978132