HAND SANITIZER- alcohol gel 
Innovative Tool and design

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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Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Directions

Other information

Inactive ingredients

Water (Aqua), Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadnsis Leaf Extract, Triethanolamine

Package Label - Principal Display panel

474 ml NDC: 78900-624-10

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HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78900-631
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSEMI-CIRCLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78900-631-10474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/26/2020
2NDC:78900-631-11237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/26/2020
Labeler - Innovative Tool and design (011289563)
Registrant - Innovative Tool and design (011289563)
Establishment
NameAddressID/FEIBusiness Operations
Innovative Tool and design011289563relabel(78900-631)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Meiteli Cosmetic co.546624772manufacture(78900-631)

Revised: 2/2021
Document Id: bc2b4f13-4bb9-c5f4-e053-2995a90aa5b1
Set id: a7d3ac4a-78bd-b059-e053-2a95a90a4d5e
Version: 5
Effective Time: 20210225
 
Innovative Tool and design