Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 80a490b4-dae5-4851-b3e6-2e558cdc51e5
Route
TOPICAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 mL)
Inactive Ingredients
Isopropyl Alcohol Water Trolamine Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Propylene Glycol Myristyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-21

Description

Ethyl Alcohol 60% v/v

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Ethyl Alcohol 60% v/v

Uses
  • For handwashing to decrease 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 50569-3

Stop use and ask a doctor if eye or skin irritation or redness occurs for more than 72 hours

Section 51727-6

Inactive ingredients water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

Warnings
  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge
Directions
  • Apply liberal amount into hand
  • Spread by rubbing hands together
  • Rub to dryness with attention to area around nails and between fingers
Do Not Use
  • In eyes
Active Ingredient

Ethyl Alcohol 60% v/v

Other Information
  • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHINGWITH SOAP AND WATER
  • For additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: In the US, call (833) 571-1403
When Using This Product
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
Principal Display Panel and Representative Label

REORDER # 644086

1111219 778372

778372/7300/0521

FIRST

MARK

The Mark of Quality In 

Non-Food Essentials

ULTRA

HAND

SANITIZER

Active Ingredient: Ethanol 60% by volume

SDS-NC-872, SDS-NJ-20007

40.6 US fl. oz. (1200 mL)

Meets the requirements for

Hand Antiseptics as specified

in section 2-301.16 of the

2017 Model Food Code.

Made in the USA

DISTRIBUTED BY:

PERFORMANCE FOOD GROUP

12500 WEST CREEK PARKWAY

RICHMOND, VIRGINIA 23238


Structured Label Content

Uses
  • For handwashing to decrease 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 50569-3 (50569-3)

Stop use and ask a doctor if eye or skin irritation or redness occurs for more than 72 hours

Section 51727-6 (51727-6)

Inactive ingredients water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

Purpose

Antiseptic handwash

Warnings
  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge
Directions
  • Apply liberal amount into hand
  • Spread by rubbing hands together
  • Rub to dryness with attention to area around nails and between fingers
Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Ethyl Alcohol 60% v/v

Other Information (Other information)
  • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHINGWITH SOAP AND WATER
  • For additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: In the US, call (833) 571-1403
When Using This Product (When using this product)
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
Principal Display Panel and Representative Label (Principal display panel and representative label)

REORDER # 644086

1111219 778372

778372/7300/0521

FIRST

MARK

The Mark of Quality In 

Non-Food Essentials

ULTRA

HAND

SANITIZER

Active Ingredient: Ethanol 60% by volume

SDS-NC-872, SDS-NJ-20007

40.6 US fl. oz. (1200 mL)

Meets the requirements for

Hand Antiseptics as specified

in section 2-301.16 of the

2017 Model Food Code.

Made in the USA

DISTRIBUTED BY:

PERFORMANCE FOOD GROUP

12500 WEST CREEK PARKWAY

RICHMOND, VIRGINIA 23238


Advanced Ingredient Data


Raw Label Data

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