de020f1f-4141-4665-9704-ccb1729bfc32

SPL v3

SPL

SPL Set ID de020f1f-4141-4665-9704-ccb1729bfc32

Route

topical

Published

Effective Date 2020-06-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (69 mL)

Inactive Ingredients

carbomer 934 trolamine glycerin water aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-16

Purpose

Antibacterial Agent

Description

Ethyl Alcohol 69% v/v

Medication Information

Warnings

For external use only.

Non Medical. Flammable. Keep away from fire or flame

When using this product, do not use in or near eyes, In case of contact, rinse eyes thoroughly with water

Active Ingredient

Ethyl Alcohol 69% v/v

Purpose

Antibacterial Agent

Directions

Place enough product in palm to thoroughly cover hands
Briskly rub hands together until dry
Children under 6 years of age should be supervised when using this product

Other Information

Store below 104F (40C)

Inactive Ingredients

Water, Carbomer, Triethanolamine, Glycerin, PEG-40 Hydrogenated Caster Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Parfum

Description

Ethyl Alcohol 69% v/v

Use

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Section 50566-9

Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours

Section 51945-4

Structured Label Content

Warnings

For external use only.

Non Medical. Flammable. Keep away from fire or flame

When using this product, do not use in or near eyes, In case of contact, rinse eyes thoroughly with water

Active Ingredient (55106-9)

Ethyl Alcohol 69% v/v

Purpose

Antibacterial Agent

Directions

Place enough product in palm to thoroughly cover hands
Briskly rub hands together until dry
Children under 6 years of age should be supervised when using this product

Other Information

Store below 104F (40C)

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Triethanolamine, Glycerin, PEG-40 Hydrogenated Caster Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Parfum

Use

For hand washing to decrease bacteria on the skin

Recommended for repeated use

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 50566-9 (50566-9)

Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours

Section 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "69", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand washing to decrease bacteria on the skin Recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away", "50566-9": "Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours", "55106-9": "Ethyl Alcohol 69% v/v", "Purpose": "Antibacterial Agent", "Warnings": "For external use only. Non Medical. Flammable. Keep away from fire or flame When using this product, do not use in or near eyes, In case of contact, rinse eyes thoroughly with water", "Directions": "Place enough product in palm to thoroughly cover hands Briskly rub hands together until dry Children under 6 years of age should be supervised when using this product", "Other Information": "Store below 104F (40C)", "Inactive ingredients": "Water, Carbomer, Triethanolamine, Glycerin, PEG-40 Hydrogenated Caster Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Parfum"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:48.310948 · Updated: 2026-03-14T22:59:56.071430