a704bced-e210-644f-e053-2a95a90a5ba9

SPL v1

SPL

SPL Set ID a704bced-e210-644f-e053-2a95a90a5ba9

Route

topical

Published

Effective Date 2020-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (70.01595407 mL)

Inactive Ingredients

glycerin carbomer 940 water hyaluronate sodium aminomethylpropanol alpha-tocopherol acetate panthenol aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-01

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 your 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, Fragrance, Aminomethyl Propanol, Aloe Barbadensis Leaf, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate

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

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 your 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, Fragrance, Aminomethyl Propanol, Aloe Barbadensis Leaf, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate

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)

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70.01595407", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "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 your 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, Fragrance, Aminomethyl Propanol, Aloe Barbadensis Leaf, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:46.395285 · Updated: 2026-03-14T22:57:01.531445