a4bf1b86-3da6-9821-e053-2995a90aaaae

SPL v2

SPL

SPL Set ID a4bf1b86-3da6-9821-e053-2995a90aaaae

Route

topical

Published

Effective Date 2020-05-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (70 mL)

Inactive Ingredients

glycerin carbomer homopolymer type b (allyl pentaerythritol crosslinked) water trolamine levomenthol hyaluronate sodium 1,2-hexanediol aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-05-04

Purpose

Antiseptic

Description

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Medication Information

Warnings

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

Uses

Hand Sanitizer to help reduce bacteria on the skin.

Purpose

Antiseptic

Directions

Place enough product on palm to cover all surfaces and rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
May discolor certain fabrics or surfaces

Inactive Ingredients

Water, Glycerin, Carbomer, Trolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Description

Ethyl alcohol 70% v/v. Purpose: Antiseptic

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

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

Active Ingredient(s)

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

500 mL NDC: 76890-101-01

Structured Label Content

Warnings

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

Uses

Hand Sanitizer to help reduce bacteria on the skin.

Purpose

Antiseptic

Directions

Place enough product on palm to cover all surfaces and rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
May discolor certain fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Trolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

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)

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

Active Ingredient(s)

Ethyl alcohol 70% v/v. Purpose: Antiseptic

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

500 mL NDC: 76890-101-01

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "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"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOMENTHOL", "unii": "BZ1R15MTK7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand Sanitizer to help reduce bacteria on the skin.", "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": "When using this product do not use in or near the eye. In case of contact with eyes, rinse thorougly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Place enough product on palm to cover all surfaces and rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces", "Active Ingredient(s)": "Ethyl alcohol 70% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, Glycerin, Carbomer, Trolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol", "Package Label - Principal Display Panel": "500 mL NDC: 76890-101-01"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:42.602509 · Updated: 2026-03-14T22:56:56.523889