C19 ANTIMICROBIAL HAND SANITIZER- alcohol gel

C19 Antimicrobial Hand Sanitizer by

Drug Labeling and Warnings

C19 Antimicrobial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 70% v/v.

PURPOSE

Antimicrobial

USE

Hand Sanitizer to help reduce pathogens on the skin.

WARNINGS

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

THIS PRODUCT IS INTENDED FOR EXTERNAL USE ONLY.

DISCONTINUE USE IF irritation or redness develops.
If condidtion persists for more than 72 hours, consult a doctor.

Do not use

DISCONTINUE USE IF irritation or redness develops.

If condition persists for more than 72 hours, consult a doctor.

WHEN USING

WHEN USING THIS PRODUCT, Do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

STOP USE

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

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 throroughly cover your hands.
• Rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

OTHER INFORMATION

• Store below 110F (44C)
• May discolor certain fabrics or surfaces

INACTIVE INGREDIENTS

Water (aqua), Hydroxyethylcellulose

Package Label

INGREDIENTS AND APPEARANCE

C19 ANTIMICROBIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	1.2 g  in 100 g
WATER (UNII: 059QF0KO0R)	34.1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-0009-1	78 g in 1 TUBE; Type 0: Not a Combination Product	04/03/2020
2	NDC: 73369-0009-2	206 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/03/2020
3	NDC: 73369-0009-4	3359 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020
4	NDC: 73369-0009-3	822 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Kabana Skin Care LLC (080237112)

Registrant - Kabana Skin Care LLC (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care LLC		080237112	manufacture(73369-0009)