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SPL v2

SPL

SPL Set ID 3e0d9970-a288-44da-8da9-6e0cd74d0e04

Route

TOPICAL

Published

Effective Date 2020-04-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Glycerin Water Carbomer 934 Aloe Vera Whole

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-29

Description

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Use

Hand sanitizer to help decrease bacteria on the skin when water and soap are not available

Recommended for repeated use

Section 42229-5

Section 44425-7

Other Information

Store at 59-86 F (15-30C)

Aviod freezing and ecessive heat above 104F (40C)

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 develops and persists

Section 50567-7

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Section 51945-4

Warnings

For external use only.

Flammable,keep away from heat and flame

Directions

Pump as needed into your palm and thoroughly spread on both hands
Rub into skin until dry without wiping
Children under 6 years of age should be supervised when using this product

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients

Water, glycerin aloe barbadensis gel, carbomer, fragrance.

Structured Label Content

Use

Hand sanitizer to help decrease bacteria on the skin when water and soap are not available

Recommended for repeated use

Section 42229-5 (42229-5)

Section 44425-7 (44425-7)

Other Information

Store at 59-86 F (15-30C)

Aviod freezing and ecessive heat above 104F (40C)

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 develops and persists

Section 50567-7 (50567-7)

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only.

Flammable,keep away from heat and flame

Directions

Pump as needed into your palm and thoroughly spread on both hands
Rub into skin until dry without wiping
Children under 6 years of age should be supervised when using this product

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin aloe barbadensis gel, carbomer, fragrance.

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 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA WHOLE", "unii": "KIZ4X2EHYX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help decrease bacteria on the skin when water and soap are not available Recommended for repeated use", "42229-5": "NA", "44425-7": "Other Information Store at 59-86 F (15-30C) Aviod freezing and ecessive heat above 104F (40C)", "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 develops and persists", "50567-7": "When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable,keep away from heat and flame", "Directions": "Pump as needed into your palm and thoroughly spread on both hands Rub into skin until dry without wiping Children under 6 years of age should be supervised when using this product", "Active Ingredient(s)": "Ethyl Alcohol 62% v/v", "Inactive ingredients": "Water, glycerin aloe barbadensis gel, carbomer, fragrance."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:45.128070 · Updated: 2026-03-14T22:59:51.166569