THE VILLAGES HAND SANITIZER WITH ALOE AND VITAMIN E EXTRACT- alcohol solution 
iHotel Guest Amenities 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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The villiages Hand Sanitizer

Ethyl Alcohol 62% 

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Non Medical. Flammable. Keep away from fire or flame

Do not use in or near eyes, In case of contact, rinse thoroughly with water

Stop use and consult a doctor if irritation or rash occurs

Keep out of reach of children. If swallowed, seek immediate medical help or contact a poison control center

Directions

Inactive ingredients

Water, Carbomer, Triethanolamine, Glycerin, Alor Barbardensis Leaf Juice, Tocopheryl Acetate

image description

THE VILLAGES HAND SANITIZER WITH ALOE AND VITAMIN E EXTRACT 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71004-103
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
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71004-103-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2020
2NDC:71004-103-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/20/2020
Labeler - iHotel Guest Amenities Co.,Ltd (421299845)
Establishment
NameAddressID/FEIBusiness Operations
iHotel Guest Amenities Co.,Ltd421299845manufacture(71004-103)

Revised: 6/2020
Document Id: a8c66cd6-57f9-179f-e053-2995a90a0be5
Set id: be1e26a7-2958-44d8-b38a-250f41200d92
Version: 1
Effective Time: 20200623
 
iHotel Guest Amenities Co.,Ltd