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SPL v1

SPL

SPL Set ID 10cb80a9-55cf-4c38-8d73-bd011c267bfa

Route

TOPICAL

Published

Effective Date 2020-08-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Water Carbomer 940 Alpha-tocopherol Acetate Trolamine Aloe Vera Leaf Propylene Glycol Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-08-14

Description

Ethyl Alcohol 70%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70%

Use

Hand sanitizer to help reduce bacteria on the 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 irritation or rash appears and lasts

Section 50567-7

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

Section 51945-4

Warnings

For external use only

Flammable. Keep away from fire or flame

Directions

Place enough product in your palm to thoroughly spread on both hands and rub into skin untill dry

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

Other Information

Store below 106F (41C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients

Water, aloe barbadensis leaf jiuce, carbomer, fragrance, glycerin, propylene glycol, triethanolamine, tocopheryl acetate, 2-(dimethylamino) ethanol, FD&C Blue 1, FD&C Yelow 5

Structured Label Content

Use

Hand sanitizer to help reduce bacteria on the 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 irritation or rash appears and lasts

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only

Flammable. Keep away from fire or flame

Directions

Place enough product in your palm to thoroughly spread on both hands and rub into skin untill dry

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

Other Information (Other information)

Store below 106F (41C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)

Water, aloe barbadensis leaf jiuce, carbomer, fragrance, glycerin, propylene glycol, triethanolamine, tocopheryl acetate, 2-(dimethylamino) ethanol, FD&C Blue 1, FD&C Yelow 5

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "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 eyes. In case of eye contact, rinse eyes thoroughly with water.", "Purpose": "Antimicrobial", "Warnings": "For external use only Flammable. Keep away from fire or flame", "Directions": "Place enough product in your palm to thoroughly spread on both hands and rub into skin untill dry Children under six years of age should be supervised when using this product", "Other information": "Store below 106F (41C) May discolor certain fabrics or surfaces", "Active Ingredient(s)": "Ethyl Alcohol 70%", "Inactive ingredients": "Water, aloe barbadensis leaf jiuce, carbomer, fragrance, glycerin, propylene glycol, triethanolamine, tocopheryl acetate, 2-(dimethylamino) ethanol, FD&C Blue 1, FD&C Yelow 5"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:29.210404 · Updated: 2026-03-14T22:58:01.908948