SPL v12
SPL
SPL Set ID 5ee820cd-2dca-40d5-bd96-bbd54131c2f0
Route
TOPICAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (377.5 mL)
Inactive Ingredients
Isopropyl Alcohol Glycerin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Diethylaminoethyl Peg-5 Cocoate Levomenol Aminomethylpropanol Methylpropanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-04-01 Until 2027-08-31

Description

Ethanol 70.0% (w/w)  (equivalent to 76.91% v/v)


Medication Information

Dosage and Administration

Apply product onto hands, spread thoroughly and rub until dry.

Description

Ethanol 70.0% (w/w)  (equivalent to 76.91% v/v)

Uses

A hand rub 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 skin irritatin or redness occurs for more than 72 hours.

Section 51727-6

Inactive ingredients Water (aqua), Isopropyl Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Cross-polymer, PEG-5 Cocoate, Bisabolol, Aminomethyl Propanol, Methylpropanediol

Section 53413-1

Questions or comments? Call (800)726-2308 Monday/Friday 9:00am to 5:00pm (UTC-4)

Section 55105-1

Antiseptic Hand Rub

Section 55106-9

Ethanol 70.0% (w/w) (equivalent to 76.91% v/v)

Warnings
  • For external use only
  • FLAMMABLE. Keep away from fire or flame, heat sparks and sources of static discharge.
Do Not Use

In eyes

Other Information
  • Store at 41 - 77 °F (5 - 25 °C)
  • See Safety Data Sheet (SDS)
  • For emergency medical information in USA, call (800)726-2308
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

ANIOSGEL

85 NPC

HAND SANITIZING

GEL HAND-RUB

Active ingredient: ethanol 70.0% w/w (equivalent to 76.91% v/v)

17 fl oz (500 mL)

Manu factured by:

Laboratoires Anios and Ecolab Company

1, rue de l'Espoir, Lezennes, France


Structured Label Content

Uses

A hand rub to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Apply product onto hands, spread thoroughly and rub until dry.

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 skin irritatin or redness occurs for more than 72 hours.

Section 51727-6 (51727-6)

Inactive ingredients Water (aqua), Isopropyl Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Cross-polymer, PEG-5 Cocoate, Bisabolol, Aminomethyl Propanol, Methylpropanediol

Section 53413-1 (53413-1)

Questions or comments? Call (800)726-2308 Monday/Friday 9:00am to 5:00pm (UTC-4)

Section 55105-1 (55105-1)

Antiseptic Hand Rub

Section 55106-9 (55106-9)

Ethanol 70.0% (w/w) (equivalent to 76.91% v/v)

Warnings
  • For external use only
  • FLAMMABLE. Keep away from fire or flame, heat sparks and sources of static discharge.
Do Not Use (Do not use)

In eyes

Other Information (Other information)
  • Store at 41 - 77 °F (5 - 25 °C)
  • See Safety Data Sheet (SDS)
  • For emergency medical information in USA, call (800)726-2308
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)

ANIOSGEL

85 NPC

HAND SANITIZING

GEL HAND-RUB

Active ingredient: ethanol 70.0% w/w (equivalent to 76.91% v/v)

17 fl oz (500 mL)

Manu factured by:

Laboratoires Anios and Ecolab Company

1, rue de l'Espoir, Lezennes, France


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)