735e9948-a199-44a4-9b1f-fc2c5bac275b

SPL v1

SPL

SPL Set ID 735e9948-a199-44a4-9b1f-fc2c5bac275b

Route

topical

Published

Effective Date 2020-07-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 L)

Inactive Ingredients

aminomethylpropanol carbomer homopolymer, unspecified type glycerin phenoxyethanol ethylhexylglycerin

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-01

Purpose

Antiseptic

Description

Alcohol 75% v/v. Purpose: Antiseptic

Medication Information

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry with wiping,

for children under 6, use under adult supervision, not recommended for infants.

Description

Alcohol 75% v/v. Purpose: Antiseptic

Uses:

To decrease bacteria on the skin that could cause disease. Recommended for repeat 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

Stop use and ask a doctor if irritation or redness develop. Condition persist for more than 72 hours.

Section 50567-7

When using this product keep out of eyes, In case of contact with eyes, rinse eyes 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 fire or flame

Other Information:

Do not store above 105°F, may discolor fabric. Harmful to wood finishing and plastic.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients:

Aminomethylpropanol, Carbomer, Glycerin, Polysorbate 20, Propylene Glycol, Water

Structured Label Content

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry with wiping,

for children under 6, use under adult supervision, not recommended for infants.

Uses:

To decrease bacteria on the skin that could cause disease. Recommended for repeat 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)

Stop use and ask a doctor if irritation or redness develop. Condition persist for more than 72 hours.

Section 50567-7 (50567-7)

When using this product keep out of eyes, In case of contact with eyes, rinse eyes thoroughly with water, avoid contact with broken skin, do not inhale or ingest.

Section 51945-4 (51945-4)

Warnings:

For external use only: Hands

Flammable, Keep away from fire or flame

Other Information: (Other information:)

Do not store above 105°F, may discolor fabric. Harmful to wood finishing and plastic.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients: (Inactive ingredients:)

Aminomethylpropanol, Carbomer, Glycerin, Polysorbate 20, Propylene Glycol, Water

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "To decrease bacteria on the skin that could cause disease. Recommended for repeat use.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or redness develop. Condition persist for more than 72 hours.", "50567-7": "When using this product keep out of eyes, In case of contact with eyes, rinse eyes 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 fire or flame", "Directions": "Wet hands thoroughly with product and allow to dry with wiping, for children under 6, use under adult supervision, not recommended for infants.", "Other information:": "Do not store above 105°F, may discolor fabric. Harmful to wood finishing and plastic.", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients:": "Aminomethylpropanol, Carbomer, Glycerin, Polysorbate 20, Propylene Glycol, Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:09.990035 · Updated: 2026-03-14T22:57:36.066065