a359d3c8-59e7-5565-e053-2a95a90a3bad

SPL v1

SPL

SPL Set ID a359d3c8-59e7-5565-e053-2a95a90a3bad

Route

topical

Published

Effective Date 2020-04-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

isopropyl alcohol (70 mL)

Inactive Ingredients

aloe vera leaf carbomer 940 water dimethicone 100 fenoprop triisopropanolamine

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-16

Purpose

Antiseptic, Hand Sanitizer

Description

This hand sanitizer is manufactured using the following ingredients: Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Aloe Barbadensis Leaf Carbomer Dimethicone Triisopropanolamine Water

Medication Information

Warnings

Flammable. Keep away from heat or flame. For external use only.

Purpose

Antiseptic, Hand Sanitizer

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105F

Inactive Ingredients

Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

Description

Use

For handwashing to decrease bacteria on the skin.

Section 42229-5

This hand sanitizer is manufactured using the following ingredients:

Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Aloe Barbadensis Leaf
Carbomer
Dimethicone
Triisopropanolamine
Water

Section 50565-1

Keep out of reach of children. If swallowed, get medical help promptly.

Section 50566-9

Stop use and ask a doctor if irritation or redness develop and persist.

Section 50567-7

Do not use in eyes. In case of contact with eyes, rinse with water.

Section 51945-4

3785ml NDC: 75498-070-01

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

237ml NDC: 75498-070-08

Structured Label Content

Warnings

Flammable. Keep away from heat or flame. For external use only.

Purpose

Antiseptic, Hand Sanitizer

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information (Other information)

Store under 105F

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

Use

For handwashing to decrease bacteria on the skin.

Section 42229-5 (42229-5)

This hand sanitizer is manufactured using the following ingredients:

Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Aloe Barbadensis Leaf
Carbomer
Dimethicone
Triisopropanolamine
Water

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help promptly.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop and persist.

Section 50567-7 (50567-7)

Do not use in eyes. In case of contact with eyes, rinse with water.

Section 51945-4 (51945-4)

3785ml NDC: 75498-070-01

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel (Package Label - Principal Display Panel)

237ml NDC: 75498-070-08

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE 100", "unii": "RO266O364U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FENOPROP TRIISOPROPANOLAMINE", "unii": "24FMI726KO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For handwashing to decrease bacteria on the skin.", "42229-5": "This hand sanitizer is manufactured using the following ingredients: Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Aloe Barbadensis Leaf Carbomer Dimethicone Triisopropanolamine Water", "50565-1": "Keep out of reach of children. If swallowed, get medical help promptly.", "50566-9": "Stop use and ask a doctor if irritation or redness develop and persist.", "50567-7": "Do not use in eyes. In case of contact with eyes, rinse with water.", "51945-4": "3785ml NDC: 75498-070-01", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "Flammable. Keep away from heat or flame. For external use only.", "Directions": "Wet hands thoroughly with product and allow to dry without wiping.", "Other information": "Store under 105F", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v. Purpose: Antiseptic", "Inactive ingredients": "Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water", "Package Label - Principal Display Panel": "237ml NDC: 75498-070-08"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:14.376531 · Updated: 2026-03-14T22:56:14.192854