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SPL v1

SPL

SPL Set ID a858155a-6345-2297-e053-2995a90a89f3

Route

TOPICAL

Published

Effective Date 2020-06-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Water Aloe Vera Leaf Sodium Hydroxide Glycerin Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-06-18

Description

Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75%

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50568-5

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50570-1

Do not use.

In children less than 2 months of age
On open skin wounds

Section 51945-4

Warnings

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

Directions

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping, Children under 6 years of age should be supervised when using this product.

Active Ingredient

Alcohol 75%

Other Information

Store below 106F 41C

Inactive Ingredients

water

aloe barbadensis extract

carbomer

glycerin

sodium hydroxide

Structured Label Content

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50568-5 (50568-5)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50570-1 (50570-1)

Do not use.

In children less than 2 months of age
On open skin wounds

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

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

Directions

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping, Children under 6 years of age should be supervised when using this product.

Active Ingredient (Active ingredient)

Alcohol 75%

Other Information (Other information)

Store below 106F 41C

Inactive Ingredients (Inactive ingredients)

water

aloe barbadensis extract

carbomer

glycerin

sodium hydroxide

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "50568-5": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50570-1": "Do not use. In children less than 2 months of age On open skin wounds", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Directions Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping, Children under 6 years of age should be supervised when using this product.", "Active ingredient": "Alcohol 75%", "Other information": "Store below 106F 41C", "Inactive ingredients": "water aloe barbadensis extract carbomer glycerin sodium hydroxide"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:58.633644 · Updated: 2026-03-14T22:57:17.559926