008 Antibacterial Hand Sanitizer

SPL v1

SPL

SPL Set ID ad390eac-ac54-797d-e053-2995a90a5333

Route

TOPICAL

Published

Effective Date 2020-04-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Aloe Vera Leaf Aminomethylpropanol Glycerin Isopropyl Myristate Carbomer Interpolymer Type A (55000 Cps) Caprylyl Glycol Water Isopropyl Alcohol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-27

Description

Ethyl Alcohol 75% v/v.

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75% v/v.

Uses

Hand sanitizer to help reduce bacteria on skin

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 imitation or rash appears and lasts.

Section 50570-1

When using this product do not use in or near the eyes

Section 55106-9

Ethyl Alcohol 75% v/v.

Warnings

Flammable. Keep away from fre or fiame

For external use only.

Directions

Directions: Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry

Children under 6 years of age should be supervised when using this product

Other Information

Store below 106F(41C).May discolor certain fabnics orsurfaces

Inactive Ingredients

Water (Aqua), Isopropyl Alcohol,Aloe Barbadensis Leat Juice, Caprylyl Glycol， Glycerin, isopropyl Miristate, Acrylates/C10-30 Alky Acrylate Crosspolymer, Amnomethyl Propanol, Fragrance(parfum)

When Using This Product

when using this product do not use in or near the eyes

In case of contact, rinse eyes thoroughly with water.

Package Label Principal Display Panel

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on skin

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 imitation or rash appears and lasts.

Section 50570-1 (50570-1)

When using this product do not use in or near the eyes

Section 55106-9 (55106-9)

Ethyl Alcohol 75% v/v.

Purpose

Antimicrobial

Warnings

Flammable. Keep away from fre or fiame

For external use only.

Directions

Directions: Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry

Children under 6 years of age should be supervised when using this product

Other Information (Other information)

Store below 106F(41C).May discolor certain fabnics orsurfaces

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol,Aloe Barbadensis Leat Juice, Caprylyl Glycol， Glycerin, isopropyl Miristate, Acrylates/C10-30 Alky Acrylate Crosspolymer, Amnomethyl Propanol, Fragrance(parfum)

When Using This Product (WHEN USING THIS PRODUCT)

when using this product do not use in or near the eyes

In case of contact, rinse eyes thoroughly with water.

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

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "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": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria on 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 imitation or rash appears and lasts.", "50570-1": "When using this product do not use in or near the eyes", "55106-9": "Ethyl Alcohol 75% v/v.", "Purpose": "Antimicrobial", "Warnings": "Flammable. Keep away from fre or fiame For external use only.", "Directions": "Directions: Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry Children under 6 years of age should be supervised when using this product", "Other information": "Store below 106F(41C).May discolor certain fabnics orsurfaces", "Inactive ingredients": "Water (Aqua), Isopropyl Alcohol,Aloe Barbadensis Leat Juice, Caprylyl Glycol， Glycerin, isopropyl Miristate, Acrylates/C10-30 Alky Acrylate Crosspolymer, Amnomethyl Propanol, Fragrance(parfum)", "WHEN USING THIS PRODUCT": "when using this product do not use in or near the eyes In case of contact, rinse eyes thoroughly with water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:31.363269 · Updated: 2026-03-14T22:58:05.187766