HAND SANITIZER- alcohol spray

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by California Interfill, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 80% v/v

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

• ON CHILDREN LESS THAN 2 MONTHS OF AGE
• ON OPEN SKIN WOUNDS

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
• SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

OTHER INFORMATION

• STORE BETWEEN 15-30°C (59-86°F)
• AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)

INACTIVE INGREDIENTS

GLYCERIN, HYDROGEN PEROXIDE, PURIFIED WATER USP

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75259-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75259-280-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/11/2020

Labeler - California Interfill, Inc. (128376311)

Establishment
Name	Address	ID/FEI	Business Operations
California Interfill, Inc.		128376311	manufacture(75259-280)