HAND SANITIZER- hand sanitizer solution 
State Industrial Products

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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State Industrial F207

Directions Apply a small amount to palm. Briskly rub, covering hands with product until dry.

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

Active Ingredient Benzalkonium Chloride 0.13% v/v

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.

Inactive Ingredients Water, Propylene Glycol, Fragrance, Tocopheryl Acetate, Tetrasodium EDTA, Cocamidoprpyl Betaine, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

Purpose Antibacterial Agent

State Gentle Fresh

HAND SANITIZER 
hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-207
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
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
PROPYLENE GLYCOL 1-MYRISTATE (UNII: 5G38I12XFT)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64542-207-411000 mL in 1 BAG; Type 0: Not a Combination Product02/14/2019
2NDC:64542-207-1750 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2019
3NDC:64542-207-46500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2019
4NDC:64542-207-91547 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/14/2019
Labeler - State Industrial Products (004520987)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(64542-207)

Revised: 8/2023
Document Id: 03a8d6f3-00f7-5ae3-e063-6294a90a91c2
Set id: a0358bc4-eeae-52a5-e053-2995a90ab54b
Version: 3
Effective Time: 20230824
 
State Industrial Products