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SPL v2

SPL

SPL Set ID 721ae1e9-9f19-4911-a3fa-ef65c0cd3298

Route

TOPICAL

Published

Effective Date 2020-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Glycerin Sulisobenzone Water Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-06

Description

Ethyl Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

Helps decrease bacteria on skin. Recommended for repeated use.

Warnings

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

Directions

pump as needed into your palmsand throughly spread on both the hands.

Do Not Apply

around eyes

Other Information

Store at 20°C (68° to 77°F).
May discolor fabrics

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

acrlates/C10-30 alkyl acrylates crosspolymer, benzophenone-4, glycerin, tocopherol, water

Principal Display Panel

NDC: 74235-075-02

Clean Rx^TM2 oz

A percentage of the proceeds from this product will be donated towards the coronavirus epidemic

HAND SANITIZER

Kills 99.999% of GERMS

With Moisturizer and Vitamin E

2 FL OZ (60 mL)

NDC: 74235-075-08

Clean Rx^TM 8 oz

A percentage of the proceeds from this product will be donated towards the coronavirus epidemic

HAND SANITIZER

Kills 99.999% of GERMS

With Moisturizer and Vitamin E

8 FL OZ (240 mL)

When Using This Product

avoid contact with eyes. In case of contact flush eyes with water.

Stop Use and Ask A Doctor

If irritation or redness develop and conditions persists for more than 72 hours.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. Children must be supervised in use of this product.

Structured Label Content

Use

Helps decrease bacteria on skin. Recommended for repeated use.

Purpose

Antiseptic

Warnings

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

Directions

pump as needed into your palmsand throughly spread on both the hands.

Do Not Apply (Do not apply)

around eyes

Other Information (Other information)

Store at 20°C (68° to 77°F).
May discolor fabrics

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

acrlates/C10-30 alkyl acrylates crosspolymer, benzophenone-4, glycerin, tocopherol, water

Principal Display Panel

NDC: 74235-075-02

Clean Rx^TM2 oz

A percentage of the proceeds from this product will be donated towards the coronavirus epidemic

HAND SANITIZER

Kills 99.999% of GERMS

With Moisturizer and Vitamin E

2 FL OZ (60 mL)

NDC: 74235-075-08

Clean Rx^TM 8 oz

A percentage of the proceeds from this product will be donated towards the coronavirus epidemic

HAND SANITIZER

Kills 99.999% of GERMS

With Moisturizer and Vitamin E

8 FL OZ (240 mL)

When Using This Product (When using this product)

avoid contact with eyes. In case of contact flush eyes with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or redness develop and conditions persists for more than 72 hours.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. Children must be supervised in use of this product.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Helps decrease bacteria on skin. Recommended for repeated use.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from fire or flame", "Directions": "pump as needed into your palmsand throughly spread on both the hands.", "Do not apply": "around eyes", "Other information": "Store at 20°C (68° to 77°F). May discolor fabrics", "Active Ingredient(s)": "Ethyl Alcohol 75%", "Inactive ingredients": "acrlates/C10-30 alkyl acrylates crosspolymer, benzophenone-4, glycerin, tocopherol, water", "Principal Display Panel": "NDC: 74235-075-02 Clean Rx TM 2 oz A percentage of the proceeds from this product will be donated towards the coronavirus epidemic HAND SANITIZER Kills 99.999% of GERMS With Moisturizer and Vitamin E 2 FL OZ (60 mL) NDC: 74235-075-08 Clean Rx TM 8 oz A percentage of the proceeds from this product will be donated towards the coronavirus epidemic HAND SANITIZER Kills 99.999% of GERMS With Moisturizer and Vitamin E 8 FL OZ (240 mL)", "When using this product": "avoid contact with eyes. In case of contact flush eyes with water.", "Stop use and ask a doctor": " If irritation or redness develop and conditions persists for more than 72 hours.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away. Children must be supervised in use of this product."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:16.337213 · Updated: 2026-03-14T22:56:17.288248