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SPL v2

SPL

SPL Set ID a3db17b9-9544-ea0b-e053-2995a90aeac1

Route

TOPICAL

Published

Effective Date 2020-04-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.3 mL)

Inactive Ingredients

Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Hyaluronate Sodium Dipropylene Glycol Levomenthol Trolamine Polyglyceryl-2 Triisostearate Water Lemon Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-27

Description

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic. Hand Sanitizer

Medication Information

Purpose

Antiseptic. Hand Sanitizer

Description

Alcohol 62% v/v. Purpose: Antiseptic

Use

For hand sanitizer to reduct microorganisms that potentially can cause diseases. Recommended for repeated use.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center immediately.

Section 50566-9

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

Section 50567-7

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

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

Section 51945-4

500mL

NDC:75504-162-11

Warnings

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

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using.

Do Not Use

in or near the eyes.In case of contact with eyes, rinse eyes thoroughly with water.

Other Information

Store below 110°F (43°C)

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Inactive Ingredients

Ethyl alcohol, Sterile Distilled water, Carbomer, Triethanolamine, Polyglyceryl-2-triisostearate, Dipropylene glycol, L-Menthol, Sodium Hyaluronate 1%, Lemon fragrance

Structured Label Content

Use

For hand sanitizer to reduct microorganisms that potentially can cause diseases. Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center immediately.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

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

Section 51945-4 (51945-4)

500mL

NDC:75504-162-11

Purpose

Antiseptic. Hand Sanitizer

Warnings

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

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using.

Do Not Use (Do not use)

in or near the eyes.In case of contact with eyes, rinse eyes thoroughly with water.

Other Information (Other information)

Store below 110°F (43°C)

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Ethyl alcohol, Sterile Distilled water, Carbomer, Triethanolamine, Polyglyceryl-2-triisostearate, Dipropylene glycol, L-Menthol, Sodium Hyaluronate 1%, Lemon fragrance

Advanced Ingredient Data

[{"name": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "DIPROPYLENE GLYCOL", "unii": "E107L85C40", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LEVOMENTHOL", "unii": "BZ1R15MTK7", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.4", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYGLYCERYL-2 TRIISOSTEARATE", "unii": "68DUY2D39A", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "34.8", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LEMON OIL", "unii": "I9GRO824LL", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand sanitizer to reduct microorganisms that potentially can cause diseases. Recommended for repeated use.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Center immediately.", "50566-9": "Stop use and ask a doctor if irritation, swelling or redness develops.", "50567-7": "When using this product do not use or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation, swelling or redness develops.", "51945-4": "500mL NDC:75504-162-11", "Purpose": "Antiseptic. Hand Sanitizer", "Warnings": "For external use on hands only. Flammable. Keep away from fire or flame.", "Directions": "Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.", "Do not use": "in or near the eyes.In case of contact with eyes, rinse eyes thoroughly with water.", "Other information": "Store below 110°F (43°C)", "Active Ingredient(s)": "Alcohol 62% v/v. Purpose: Antiseptic", "Inactive ingredients": "Ethyl alcohol, Sterile Distilled water, Carbomer, Triethanolamine, Polyglyceryl-2-triisostearate, Dipropylene glycol, L-Menthol, Sodium Hyaluronate 1%, Lemon fragrance"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:11.261916 · Updated: 2026-03-14T22:59:04.734496