Hand Sanitizer

SPL v1

SPL

SPL Set ID a830f7de-7982-7c99-e053-2a95a90aa6cb

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Carbomer 1342 Water Trolamine Fragrance Lavender & Chia F-153480 Aloe Vera Leaf Polyoxyl 40 Hydrogenated Castor Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl alcohol 70%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70%

Use

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep sealed when not in use

Section 50566-9

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

Section 50567-7

When using this product

keep out of eyes

In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin

do not inhale or ingest

Warnings

For external use only: hands

Flammable, keep away from fire or flame

Directions

wet hands thoroughly with product and allow to dry without wiping, for children under 6, use only under adult supervision

not recommended for infants

Do Not Use

Other Information

do not store above 41 C(106 F) may discolor some fabrics harmful to wood finishes and plastics

Active Ingredient(s)

Ethyl alcohol 70%

Inactive Ingredients

water(aqua), glycerin, carbomer, triethanolamine, peg-40 hydrogenated castor oil, fragrance(parfum), aloe barbadensis leaf extract, tocopheryl acetate

Package Label Principal Display Panel

Structured Label Content

Use

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep sealed when not in use

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product

keep out of eyes

In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin

do not inhale or ingest

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable, keep away from fire or flame

Directions

wet hands thoroughly with product and allow to dry without wiping, for children under 6, use only under adult supervision

not recommended for infants

Do Not Use (Do not use)

Other Information (Other information)

do not store above 41 C(106 F) may discolor some fabrics harmful to wood finishes and plastics

Active Ingredient(s)

Ethyl alcohol 70%

Inactive Ingredients (Inactive ingredients)

water(aqua), glycerin, carbomer, triethanolamine, peg-40 hydrogenated castor oil, fragrance(parfum), aloe barbadensis leaf extract, tocopheryl acetate

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

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 1342", "unii": "809Y72KV36", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE LAVENDER & CHIA F-153480", "unii": "SXS9CO2TZK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "to decrease bacteria on the skin that could cause disease recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep sealed when not in use", "50566-9": "Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours", "50567-7": "When using this product keep out of eyes In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest", "Purpose": "Antiseptic", "Warnings": "For external use only: hands Flammable, keep away from fire or flame", "Directions": "wet hands thoroughly with product and allow to dry without wiping, for children under 6, use only under adult supervision not recommended for infants", "Do not use": "/", "Other information": "do not store above 41 C(106 F) may discolor some fabrics harmful to wood finishes and plastics", "Active Ingredient(s)": "Ethyl alcohol 70%", "Inactive ingredients": "water(aqua), glycerin, carbomer, triethanolamine, peg-40 hydrogenated castor oil, fragrance(parfum), aloe barbadensis leaf extract, tocopheryl acetate"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:56.009385 · Updated: 2026-03-14T22:57:15.604123