61010-1112, Instant Hand Sanitizer

SPL v6

SPL

SPL Set ID c3f0556d-f967-4f19-922c-57a2bf184892

Route

TOPICAL

Published

Effective Date 2022-02-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (665 mL)

Inactive Ingredients

Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf D&c Green No. 5 D&c Yellow No. 10 Water Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-03-22

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses

for handwashing to decrease bacteria on skin without soap and water
recommended for repeated use

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of childrenIf ingested get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask doctor ifirritation and redness develop and persists for more than 72 hours

Section 50570-1

Do not usein the eyes. If this happens, rinse thoroughly with water

Warnings

For external use only

Flammable, keep away from fire or flame

Directions

wet hands & wrists thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

Active Ingredients

Ethyl Alcohol 66.5%

Inactive Ingredients

aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

Principal Display Panel – 8 Fl. Oz. Bottle Label

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

8.0 FL. OZ. (237 ML)

Structured Label Content

Uses

for handwashing to decrease bacteria on skin without soap and water
recommended for repeated use

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of childrenIf ingested get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask doctor ifirritation and redness develop and persists for more than 72 hours

Section 50570-1 (50570-1)

Do not usein the eyes. If this happens, rinse thoroughly with water

Purpose

Antiseptic

Warnings

For external use only

Flammable, keep away from fire or flame

Directions

wet hands & wrists thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

Active Ingredients

Ethyl Alcohol 66.5%

Inactive Ingredients (Inactive ingredients)

aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

Principal Display Panel – 8 Fl. Oz. Bottle Label (PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label)

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

8.0 FL. OZ. (237 ML)

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C GREEN NO. 5", "unii": "8J6RDU8L9X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "665", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "L"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for handwashing to decrease bacteria on skin without soap and water recommended for repeated use", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children If ingested get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours", "50570-1": "Do not use in the eyes. If this happens, rinse thoroughly with water", "Purpose": "Antiseptic", "Warnings": "For external use only Flammable, keep away from fire or flame", "Directions": "wet hands & wrists thoroughly with product allow to dry without wiping children under 6 should be supervised while using this product", "Active Ingredients": "Ethyl Alcohol 66.5%", "Inactive ingredients": "aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com", "PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label": "Safetec instant Hand Sanitizer Kills 99.9% of Germs Enriched with Aloe Vera Fresh 8.0 FL. OZ. (237 ML)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:16.494838 · Updated: 2026-03-14T23:12:26.991151