SEPTIHOL HAND SANITIZER- alcohol aerosol, foam

Septihol Hand Sanitizer by

Drug Labeling and Warnings

Septihol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by STERIS Corporation, Accra Pac, Inc. (Voyant Beauty). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 62% v/v

Purposes

Antiseptic

Uses

To help decrease bacteria/germs on the skin that could cause disease. For use when soap and water are not available. Recommended for repeated use.

Warnings

For external use only. Flammable, keep away from fire or flame. Do not puncture or incinerate. Do not store above 120ºF (49ºC).

When using this product

Avoid contact with eyes. If splashed in eyes, rinse immediately and thoroughly with water. Do not use on open wounds, Discontinue use if irritation/redness occurs.

Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing until hands feel dry. Do not rinse or wipe off sanitizer.

Other Information

For best foam density store and use at a temperature of 55 - 85˚F (13 - 29˚C)

Inactive Ingredients

Water, Hydrofluorocarbon 152a, Isobutane, Emulsifying Wax, Cetyl lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

STERIS®

SEPTIHOL™

HAND SANITIZER

Reorder Number:
625736

Contents:
9 oz (255g)

NDC# 0519-6257-36

Antiseptic

No-Rinse

62% Ethyl Alcohol by Volume

Manufactured for: STERIS Corporation
7501 Page Avenue ■ St. Louis, MO 63133 ■ USA
800-548-4873 ■ www.steris.com

INGREDIENTS AND APPEARANCE

SEPTIHOL HAND SANITIZER 
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0519-6257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
1,1-Difluoroethane (UNII: 0B1U8K2ME0)
Isobutane (UNII: BXR49TP611)
Cetyl lactate (UNII: A7EVH2RK4O)
Steareth-2 (UNII: V56DFE46J5)
Sodium Benzoate (UNII: OJ245FE5EU)
SODIUM SESQUICARBONATE (UNII: Y1X815621J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0519-6257-35	24 in 1 CASE	05/01/2021
1	NDC: 0519-6257-36	255 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M003	05/01/2021

Labeler - STERIS Corporation (139424188)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc. (Voyant Beauty)		024213616	MANUFACTURE(0519-6257)