FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E- foaming instant hand sanitizer with aloe and vitamin e solution 
Kutol Products Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Foaming Instant Hand Sanitizer with Aloe and Vitamin E

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

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

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

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.

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

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. If swallowed, contact a physician or poison control center.

Foaming Instant 1000 mL 532 mL Foaming Instant 1250 mL Foaming Instant 3.785 L Foaming Instant 950 mL Foaming Instant 532 mL

FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E 
foaming instant hand sanitizer with aloe and vitamin e solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-207-03208175 mL in 1 DRUM; Type 0: Not a Combination Product05/31/2016
2NDC:50865-207-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
3NDC:50865-207-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
4NDC:50865-207-241000 mL in 1 BAG; Type 0: Not a Combination Product05/31/2016
5NDC:50865-207-311000 mL in 1 BAG; Type 0: Not a Combination Product05/31/2016
6NDC:50865-207-411000 mL in 1 BAG; Type 0: Not a Combination Product05/31/2016
7NDC:50865-207-78950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
8NDC:50865-207-91532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2016
Labeler - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(50865-207) , analysis(50865-207) , label(50865-207) , pack(50865-207)

Revised: 1/2019
Document Id: 7f98884b-0337-c15e-e053-2a91aa0acef0
Set id: 3429c36b-47af-5ff9-e054-00144ff88e88
Version: 3
Effective Time: 20190116
 
Kutol Products Company, Inc.