00e15fc7-133e-beb2-e063-6294a90a1698

SPL v2

SPL

SPL Set ID 00e15fc7-133e-beb2-e063-6294a90a1698

Route

topical

Published

Effective Date 2023-07-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (70 mL)

Inactive Ingredients

glycerin aloe vera leaf triethanolamine dodecylbenzenesulfonate water lemon oil carbomer interpolymer type b (allyl pentaerythritol crosslinked)

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2023-07-25

Purpose

Antiseptic

Description

Alcohol 70% v/v

Medication Information

Uses

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

Purpose

Antiseptic

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using products.

Other Information

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive Ingredients

Aloe Vera, Carbomer Interpolymer (type B)，Lemon oil， Glycerin, Triethanolamine, Water (Aqua).

Description

Alcohol 70% v/v

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 occurs. These may be signs of a serious condition.

Section 50567-7

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

Wamings

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

Do Not Use

• On children less than 2 months of age. • On open skin wounds.

Active Ingredient(s)

Alcohol 70% v/v

Package Label.principal Display Panel

Structured Label Content

Uses

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

Purpose

Antiseptic

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using products.

Other Information (Other information)

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Carbomer Interpolymer (type B)，Lemon oil， Glycerin, Triethanolamine, Water (Aqua).

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 occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Wamings

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

Do Not Use (Do not use)

• On children less than 2 months of age. • On open skin wounds.

Active Ingredient(s)

Alcohol 70% v/v

Package Label.principal Display Panel (Package label.principal display panel)

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE DODECYLBENZENESULFONATE", "unii": "8HM7ZD48HN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON OIL", "unii": "I9GRO824LL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "132584PQMO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Wamings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "• Put enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be supervised when using products.", "Do not use": "• On children less than 2 months of age. • On open skin wounds.", "Other information": "• Store below 110°F (43°C). • Avoid freezing and excessive heat above 104°F (40°C). • May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Alcohol 70% v/v", "Inactive ingredients": "Aloe Vera, Carbomer Interpolymer (type B)，Lemon oil， Glycerin, Triethanolamine, Water (Aqua)."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:02.438599 · Updated: 2026-03-14T23:01:15.754566