FOAMING HAND SANITIZER- indulgence hand sanitizer solution

Foaming Hand Sanitizer by

Drug Labeling and Warnings

Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by US Chemical Corporation, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions Apply a small amount to palm. Briskly rub, covering hands with product until dry. Children under 6 years of age should be supervised when using this product.

INACTIVE INGREDIENT

Inactive Ingredients Water, PEG-10 Dimethicone, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

INDICATIONS & USAGE

Uses Hand sanitizer to help reduce bacteria on the skin that could cause diease. Recommended for repeated use.

ACTIVE INGREDIENT

Active Ingredient Ethyl Alcohol 62% v/v

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.

PURPOSE

Purpose Antibacterial Agent

WARNINGS

Warnings For external use only. Flammable. Keep away from fire or flame. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop use and ask a doctor if irritation or rash appears and persists.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING HAND SANITIZER 
indulgence hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61307-688
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
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61307-688-10	1000 mL in 1 BAG; Type 0: Not a Combination Product	07/03/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/03/2012

Labeler - US Chemical Corporation (031457842)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(61307-688)