CLEAN SKIN SANITIZER- hand sanitizer solution

Clean Skin Sanitizer by

Drug Labeling and Warnings

Clean Skin Sanitizer by is a Otc medication manufactured, distributed, or labeled by State Industrial Products, Kutol Product Company, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

INDICATIONS & USAGE

Uses For hand cleaning to decrease bacteria on skin.

WARNINGS

Warnings For exernal use only. FLAMMABLE. Keep away from heat or flame. Do not use in the eyes. In case of contact rinse thoroughly. Stp use and ask a doctor if irritation and redness appears and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children. If swallowed, contact a physician or poison control center.

ACTIVE INGREDIENT

Active Ingredient Ethyl Alcohol 62% v/v

PURPOSE

Purpose Antibacterial Agent

INACTIVE INGREDIENT

Inactive Ingredients Water, Acrylates/C10-30 Alkyl Acrylate Crossploymer, Propylene Glycol, Glycerine, Aloe Vera Gel, Fragrance, Triisopropanolamine, Blue 1, Yellow 5.

PRINCIPAL DISPLAY PANEL

Principal Label

INGREDIENTS AND APPEARANCE

CLEAN SKIN SANITIZER 
hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64542-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64542-300-46	675 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2014
2	NDC: 64542-300-35	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/14/2014

Labeler - State Industrial Products (004520987)

Registrant - Kutol Product Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(64542-300)