drug facts

drug facts
SPL v3
SPL
SPL Set ID efbd0d15-1581-4623-8204-3ed6af32fac3
Route
topical
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (76.9 mL)
Inactive Ingredients
water isopropyl alcohol bis-peg-12 dimethicone (500 mpa.s) glycerin ethylhexylglycerin myristyl alcohol niacinamide .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-08-28

Purpose

Antiseptic handwash

Description

Ethyl alcohol 70% w/w (equivalent to 76.9% v/v)


Medication Information

Warnings
  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge
Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry
Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1-877-231-2615 (USA) If located outside the USA, call collect 1-952-853-1713
Description

Ethyl alcohol 70% w/w (equivalent to 76.9% v/v)

Questions?

Call 1-800-529-5458

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, PEG-10 dimethicone, glycerin, ethylhexylglycerin, myristyl alcohol, niacinamide, tocopheryl acetate

Do Not Use
  • in eyes
Active Ingredient

Ethyl alcohol 70% w/w (equivalent to 76.9% v/v)

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

QSR

Foaming Alcohol

Hand Sanitizer

Sanitizante de manos alcohol en espuma

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

MANTENGASE FUERA DEL ALCANCE DE LOS NIÑOS • SOLO PARA USO INSTITUCIONAL

Active ingredient | Ingrediente activo:

Ethanol 70% w/w (equivalent to 76.9% v/v)

Net contents: 25 US fl oz (750 ml)

Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Model Food Code.

Cumple con los requisitos estipulados de antisépticos para manos tal como se especifican en la sección  2-301.16 del Código Modelo para limentos (2017 Model Food Code).

SDA-NC-872, SDS-NJ-20007

Distributed by / Distribuido por:

Kay Chemical Company · 8300 Capital Drive · Greensboro NC 27409-9790 USA Customer Service: (800) 529-5458

©2020 Kay Chemical Company

All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

KUSA 777563/8000/0820

This product may be patented | Este producto puede ser patentado:

www.ecolab.com/patents


Structured Label Content

Warnings
  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge
Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry
Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1-877-231-2615 (USA) If located outside the USA, call collect 1-952-853-1713
Questions?

Call 1-800-529-5458

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, PEG-10 dimethicone, glycerin, ethylhexylglycerin, myristyl alcohol, niacinamide, tocopheryl acetate

Do Not Use (Do not use)
  • in eyes
Active Ingredient

Ethyl alcohol 70% w/w (equivalent to 76.9% v/v)

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)

QSR

Foaming Alcohol

Hand Sanitizer

Sanitizante de manos alcohol en espuma

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

MANTENGASE FUERA DEL ALCANCE DE LOS NIÑOS • SOLO PARA USO INSTITUCIONAL

Active ingredient | Ingrediente activo:

Ethanol 70% w/w (equivalent to 76.9% v/v)

Net contents: 25 US fl oz (750 ml)

Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Model Food Code.

Cumple con los requisitos estipulados de antisépticos para manos tal como se especifican en la sección  2-301.16 del Código Modelo para limentos (2017 Model Food Code).

SDA-NC-872, SDS-NJ-20007

Distributed by / Distribuido por:

Kay Chemical Company · 8300 Capital Drive · Greensboro NC 27409-9790 USA Customer Service: (800) 529-5458

©2020 Kay Chemical Company

All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

KUSA 777563/8000/0820

This product may be patented | Este producto puede ser patentado:

www.ecolab.com/patents


Advanced Ingredient Data


Raw Label Data

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