4778d80a-a4b2-46c4-8dbe-783fc40b6ea3

SPL v1

SPL

SPL Set ID 4778d80a-a4b2-46c4-8dbe-783fc40b6ea3

Route

topical

Published

Effective Date 2020-04-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (62 mL)

Inactive Ingredients

glycerin water carbomer 934 triethanolamine sulfate aloe vera whole propylene glycol .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-23

Purpose

Antiseptic

Description

Medication Information

Warnings

For external use only.

Flammable. Keep away from fire or flame

Purpose

Antiseptic

Directions

Wet hands thoroughly with products and rub into skin until dry

Other Information

Store at 20C (68-77F)

May discolor fabrics

Inactive Ingredients

Water, triethanolamine, carbomer, aloe barbadensis gel, fragrance, glycerin, propylene glycol, tocopheryl acetate (Vitamin E)

Description

Use

Hand sanitizer to help reduce bacteria on the skin

When water, soap, and towel are not available

Recommended for repeaded use

Section 42229-5

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours

Section 50567-7

Do not apply around eyes

Do not use in ears and mouth

When using this product avoid contact with eyes. In case of contact, flush eyes with water.

Section 51945-4

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Structured Label Content

Warnings

For external use only.

Flammable. Keep away from fire or flame

Purpose

Antiseptic

Directions

Wet hands thoroughly with products and rub into skin until dry

Other Information (Other information)

Store at 20C (68-77F)

May discolor fabrics

Inactive Ingredients (Inactive ingredients)

Water, triethanolamine, carbomer, aloe barbadensis gel, fragrance, glycerin, propylene glycol, tocopheryl acetate (Vitamin E)

Use

Hand sanitizer to help reduce bacteria on the skin

When water, soap, and towel are not available

Recommended for repeaded use

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours

Section 50567-7 (50567-7)

Do not apply around eyes

Do not use in ears and mouth

When using this product avoid contact with eyes. In case of contact, flush eyes with water.

Section 51945-4 (51945-4)

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE SULFATE", "unii": "MV1V89M17O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA WHOLE", "unii": "KIZ4X2EHYX", "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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce bacteria on the skin When water, soap, and towel are not available Recommended for repeaded use", "42229-5": "NA", "50565-1": "Keep out of reach of children. Children must be supervised in use of this product.", "50566-9": "Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours", "50567-7": "Do not apply around eyes Do not use in ears and mouth When using this product avoid contact with eyes. In case of contact, flush eyes with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from fire or flame", "Directions": "Wet hands thoroughly with products and rub into skin until dry", "Other information": "Store at 20C (68-77F) May discolor fabrics", "Active Ingredient(s)": "Ethyl Alcohol 62% v/v", "Inactive ingredients": "Water, triethanolamine, carbomer, aloe barbadensis gel, fragrance, glycerin, propylene glycol, tocopheryl acetate (Vitamin E)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:18.902684 · Updated: 2026-03-14T22:56:23.528867