b9e6f96b-ad06-e89f-e053-2995a90ab942

SPL v2

SPL

SPL Set ID b9e6f96b-ad06-e89f-e053-2995a90ab942

Route

topical

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (70 mL)

Inactive Ingredients

peg-12 dimethicone aloe vera leaf fragrance clean orc0600327 caprylyl glycol glycerin water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-30

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
Children under 6 years of age should be supervised when using this product.

Other Information

Store below 110FC (43C).
May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, PEG-12 Dimethicone, Carprylyl Glycol, Aloe Vera, Glycerin, Fragrance

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin that can 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 rash appears and lasts.

Section 50567-7

Do not use in or near the eyes. in case of contact, rinse thoroughly with water.

Do Not Use

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

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

473.2 mL NDC: 78257-916-01

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
Children under 6 years of age should be supervised when using this product.

Other Information (Other information)

Store below 110FC (43C).
May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water, PEG-12 Dimethicone, Carprylyl Glycol, Aloe Vera, Glycerin, Fragrance

Use

Hand Sanitizer to help reduce bacteria on the skin that can 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 rash appears and lasts.

Section 50567-7 (50567-7)

Do not use in or near the eyes. in case of contact, rinse thoroughly with water.

Do Not Use (Do not use)

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

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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

473.2 mL NDC: 78257-916-01

Advanced Ingredient Data

[{"name": "PEG-12 DIMETHICONE", "unii": "ZEL54N6W95", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE CLEAN ORC0600327", "unii": "329LCV5BTF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer to help reduce bacteria on the skin that can 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 rash appears and lasts.", "50567-7": "Do not use in or near the eyes. in case of contact, rinse thoroughly with water.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "Flammable. Keep away from heat or flame, For external use only.", "Directions": "Place enough product in your palm to thorougly cover your hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.", "Do not use": "In children less than 2 months of age On open skin wounds", "Other information": "Store below 110FC (43C). May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, PEG-12 Dimethicone, Carprylyl Glycol, Aloe Vera, Glycerin, Fragrance", "Package Label - Principal Display Panel": "473.2 mL NDC: 78257-916-01"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.479211 · Updated: 2026-03-14T23:00:25.149305