FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E solution

Foaming Instant Hand Sanitizer with Aloe and Vitamin E by

Drug Labeling and Warnings

Foaming Instant Hand Sanitizer with Aloe and Vitamin E by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13% w/w.....Antibacterial Agent

INACTIVE INGREDIENT

Water, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, Propylene Glycol, Phenoxyethanol, PEG-7 Glyceryl Cocoate, Tetrasodium EDTA.

PURPOSE

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

WARNINGS

For external use only.

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a physician or poison control center.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E 
foaming instant hand sanitizer with aloe and vitamin e solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-207-03	208175 mL in 1 DRUM; Type 0: Not a Combination Product	05/31/2016
2	NDC: 50865-207-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
3	NDC: 50865-207-17	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
4	NDC: 50865-207-24	1000 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2016
5	NDC: 50865-207-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2016
6	NDC: 50865-207-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2016
7	NDC: 50865-207-78	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
8	NDC: 50865-207-91	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/31/2016

Labeler - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(50865-207) , analysis(50865-207) , label(50865-207) , pack(50865-207)