HAND SANITIZER 500ML- ethyle alcohol gel 
E.CIS Cosmetic 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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EPU Hand Sanitizer 500ml

Active Ingredient

Ethyl Alcohol 70% v/v..........................Antiseptic ACTIVE

Purpose

Purpose.Antiseptic

PURPOSE

Use[s]

Use[s]-Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Use[s]

Warnings

Warnings-For external use only. Flammable. Keep away from heat or flame

Warnings

Do not use

Do not use-in children less than 2 months of age, on open skin wounds

Do not use

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

When using this product

Stop use and ask a doctor

Stop use and ask a doctor-if irritation or rash occurs. These may be signs of a serious condition.

Stop use and ask a doctor

Keep out of reach of children

Keep out of reach of children- If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Directions

Directions-Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Directions

Other Information

Other Information. Storage and Handling-Store between 15-30C (59-86F), ▪ Avoid freezing and excessive heat above 40C (104F)

Other Information

Inactive ingredients

Inactive ingredients-Water, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract

Inactive ingredients

Questions or Comments

Questions or Comments 1-800-819-4159

Questions or Comments

Principal Display Panel

EPU INSTANT HAND SANITIZER NON-STERILE SOLUTION Help Reduce Bacteria On The Skin.
For all day use, No Sticky, Deep Moisturizing, 500 mL (16.9 fl. oz.)

PDP

HAND SANITIZER 500ML 
ethyle alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73862-202
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73862-202-1124 in 1 CASE04/01/2020
1NDC:73862-202-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - E.CIS Cosmetic Co.,Ltd (689846270)
Registrant - E.CIS Cosmetic Co.,Ltd (689846270)
Establishment
NameAddressID/FEIBusiness Operations
E.CIS Cosmetic Co.,Ltd689846270manufacture(73862-202)

Revised: 8/2020
Document Id: add63767-362a-6f3c-e053-2a95a90a4a84
Set id: a231b1f3-d26b-22dc-e053-2995a90a9135
Version: 6
Effective Time: 20200827
 
E.CIS Cosmetic Co.,Ltd