PROTECT BY HAND SANITIZER GEL (ETHANOL)- alcohol gel 
Ken Company Co., Ltd.

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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Drug Facts

alcohol

Water
Glycerin
Carbomer
Triethanolamine
Rosmarinus Officinalis (Rosemary) Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Rose Centifolia Flower Water
Citrus Aurantium Dulcis (Orange) Oil
Limonene

Sterilization of hands and skin

KEEP OUT OF REACH OF THE CHILDREN

Apply an appropriate amount on your hands and rub well to dry.

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and
ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the
mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).
4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.
6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.
7) Do not use for any other purpose.
4. Precautions for storage
1) Avoid shading and keep in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign
Objects.

for external use only

label

PROTECT BY HAND SANITIZER GEL (ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80594-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TROLAMINE (UNII: 9O3K93S3TK)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
ORANGE OIL (UNII: AKN3KSD11B)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80594-0001-160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/2020
Labeler - Ken Company Co., Ltd. (694883411)
Registrant - Ken Company Co., Ltd. (694883411)
Establishment
NameAddressID/FEIBusiness Operations
Skin n Skin Co., Ltd.631090037manufacture(80594-0001)
Establishment
NameAddressID/FEIBusiness Operations
Ken Company Co., Ltd.694883411label(80594-0001)

Revised: 9/2020
Document Id: af51c93b-c287-74f7-e053-2a95a90ac8a5
Set id: af51cc6b-eda6-dd90-e053-2995a90a508d
Version: 1
Effective Time: 20200914
 
Ken Company Co., Ltd.