FOAMING HAND SANITIZER- ethyl alcohol 62% liquid 
RJ Schinner

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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RJ Schinner F688F

Dosage & Administration Section

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

Inactive Ingredient Section

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

Indication & Usage Section

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

OTC-Keep Out of Reach of Children

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

Purpose Section

Purpose Antibacterial Agent

OTC - Active Ingredient Section

Active Ingredient Ethyl Alcohol 62% v/v

Warnings Section

Warnings

For external use only.

Avoid contact with eyes. If eye 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.

Principal Display Panel

Principal Display Panel

FOAMING HAND SANITIZER 
ethyl alcohol 62% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71303-688
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71303-688-311000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
2NDC:71303-688-411000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/30/2017
Labeler - RJ Schinner (023432909)
Registrant - Kutol Products, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products, Inc.004236139manufacture(71303-688)

Revised: 8/2023
Document Id: 03a904f5-0641-f1e2-e063-6294a90af80e
Set id: 9cbea39d-4e07-90a8-e053-2a95a90a580c
Version: 4
Effective Time: 20230824
 
RJ Schinner