SANI-X HAND SANITIZER- ethyl alcohol gel

SANI-X HAND SANITIZER by

Drug Labeling and Warnings

SANI-X HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Formology Lab Inc., Expackusa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

TO DECREASE BACTERIA ON THE SKIN THAT POTENTIALLY CAN CAUSE DISEASE

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE IN THE EYES.

STOP USE AND ASK A DOCTOR IF IRRITATION OR PAIN OCCURS.

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

• APPLY A SUFFICIENT AMOUNT OF PRODUCT TO YOUR PALM TO COVER BOTH HANDS.
• RUB UNTIL DRY.

OTHER INFORMATION

STORE BELOW 110F (43C)

INACTIVE INGREDIENTS

AQUA, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, HYDROXYETHYLCELLULOSE, CITRUS LIMON PEEL OIL.

QUESTIONS?

CALL TOLL-FREE 1-866-942-9598 OR VISIT WWW.SANI-EX.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANI-X HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72580-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72580-302-12	45 mL in 1 TUBE; Type 0: Not a Combination Product	03/31/2020
2	NDC: 72580-302-51	500 mL in 1 POUCH; Type 0: Not a Combination Product	03/31/2020
3	NDC: 72580-302-05	1.5 mL in 1 POUCH; Type 0: Not a Combination Product	03/31/2020
4	NDC: 72580-302-11	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

Labeler - Formology Lab Inc. (081102403)

Establishment
Name	Address	ID/FEI	Business Operations
Formology Lab Inc.		081102403	manufacture(72580-302)

Establishment
Name	Address	ID/FEI	Business Operations
Expackusa, Inc.		079234982	pack(72580-302)