Sani Stix by X Auto Inc. / Doehler USA Inc. SANI STIX- alcohol gel

Sani Stix by

Drug Labeling and Warnings

Sani Stix by is a Otc medication manufactured, distributed, or labeled by X Auto Inc., Doehler USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Ethanol alcohol 71.5%

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:

in 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 with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

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 whenusing this product to avoid swallowing.

Other information:

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients:

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

INGREDIENTS AND APPEARANCE

SANI STIX 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79245-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.715 mL  in 1 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: 79245-000-00	36 in 1 PACKAGE	04/01/2020
1		3.5 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

Labeler - X Auto Inc. (782784912)

Establishment
Name	Address	ID/FEI	Business Operations
Doehler USA Inc.		040455356	manufacture(79245-000) , label(79245-000) , pack(79245-000) , repack(79245-000)