HAND SANITIZER- hand sanitizer gel 
Fortress Expert 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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HAND SANITIZER

Active ingredient

Alcohol 75%v/v..

Purpose

Antiseptic

Uses

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination on contact

Recommended for repeated use

Warnings

For external use only

Flammable, Keep away from fire or flame.

·Do not use near eyes

·In case of eye contact flush with water for 15 minutes

·If irritation persists stop use of product and get medical attention

Keep out of reach of children

In case of accidental ingestion seek medical attention or

contact a poison control center immediately.

Directions

Wet hands thoroughly with product and rub completely covering hands

·Allow to dry without wiping

·Children under the age of 6 should use with adult supervision

Not recommended for infants

Other information

Inactive ingredients

Water(Aqua) ,PEG-40 Hydrogenated Castor Oil,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance

(Parfum) , Aminomethyl Propanol.

Package Label Principal Display Panel

250 ml label 250ml 250ml 500ml label 500 ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73549-007
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73549-007-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
2NDC:73549-007-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/24/2020
Labeler - Fortress Expert Co., Ltd (543358697)
Registrant - Fortress Expert Co., Ltd (543358697)
Establishment
NameAddressID/FEIBusiness Operations
Fortress Expert Co., Ltd543358697manufacture(73549-007)

Revised: 6/2020
Document Id: a8cfd95d-8929-99a4-e053-2995a90abdad
Set id: a8cfd740-ec5b-841b-e053-2995a90a6db1
Version: 1
Effective Time: 20200624
 
Fortress Expert Co., Ltd