Hand Sanitizer

SPL v1

SPL

SPL Set ID aa8c82d8-8836-e5d4-e053-2995a90abe92

Route

TOPICAL

Published

Effective Date 2020-07-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Carbomer Homopolymer, Unspecified Type Tea Tree Oil Water Trolamine Tocopherol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-10

Description

Ethyl Alcohol 75%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75%

Use

Hand sanitizer to help reduce germs on skin that could cause disease.

Recommended for repeated use.

Label

Section 50565-1

Keep out of reach for 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, rash, or redness develops and lasts.

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.

Warnings

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

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

with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, rash, or redness develops and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product.

Do Not Use

Other Information

Store below 106ºF. (41 ºC).

May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Water, Carbomer (Gel), Melaleuca Oil (Tea Tree Oil), Aloe Barbadensis Leaf Extract

(Aloe), Tocopherols (Vitamin E),Triethaolamine (Tea)

Structured Label Content

Use

Hand sanitizer to help reduce germs on skin that could cause disease.

Recommended for repeated use.

Label

Section 50565-1 (50565-1)

Keep out of reach for 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, rash, or redness develops and lasts.

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.

Purpose

Antimicrobial

Warnings

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

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

with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, rash, or redness develops and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product.

Do Not Use (Do not use)

Other Information (Other information)

Store below 106ºF. (41 ºC).

May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water, Carbomer (Gel), Melaleuca Oil (Tea Tree Oil), Aloe Barbadensis Leaf Extract

(Aloe), Tocopherols (Vitamin E),Triethaolamine (Tea)

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce germs on skin that could cause disease. Recommended for repeated use.", "50565-1": "Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation, rash, or redness develops and lasts.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Antimicrobial", "Warnings": "For external use only: hands.Flammable. Keep away from heat, fire, or flame. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation, rash, or redness develops and lasts. Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.", "Do not use": "/", "Other information": "Store below 106ºF. (41 ºC). May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Ethyl Alcohol 75%", "Inactive ingredients": "Water, Carbomer (Gel), Melaleuca Oil (Tea Tree Oil), Aloe Barbadensis Leaf Extract (Aloe), Tocopherols (Vitamin E),Triethaolamine (Tea)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:13.507855 · Updated: 2026-03-14T22:57:39.571374