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

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

Benzethonium Chloride 0.2% 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.

Instant Foaming Hand Sanitizerinstant foaming hand sanitizer

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:43196-207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE7.56 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:43196-207-1750 mL in 1 BAG; Type 0: Not a Combination Product07/05/2016
2NDC:43196-207-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/05/2016
Labeler - OPI Correctional Industries (809174501)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(43196-207)

Revised: 7/2016
Document Id: 36e630f3-c6fa-27aa-e054-00144ff8d46c
Set id: 36e5c6e1-d4cd-642b-e054-00144ff88e88
Version: 2
Effective Time: 20160705
 
OPI Correctional Industries