XANITIZE- alcohol solution

Xanitize by

Drug Labeling and Warnings

Xanitize by is a Otc medication manufactured, distributed, or labeled by ICM Distributing Company, INC, Cospro Development Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product do not use in or near eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash 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

• Place enough product in your palm to cover hands and rub hands together briskly until dry. 
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 110°F (43°C)

Inactive ingredients

deionized water, glycerin, polysorbate 20, aloe leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

XANITIZE 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77516-111
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
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ORANGE PEEL (UNII: TI9T76XD44)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77516-111-01	242 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020
2	NDC: 77516-111-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020

Labeler - ICM Distributing Company, INC (780594458)

Registrant - Cospro Development Corp (785638821)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	manufacture(77516-111) , label(77516-111) , pack(77516-111)