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

Ethyl 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) ,Acrylates/C10-30 Alkyl Acrylate Grosspolymer,Aminomethyl Propanol.

Package Label Principal Display Panel

50ml 60ml 100ml label 250ml 300ml 480ml label 500ml 750ml 946.35ml label 950ml 2000ml 3785.4ml label 30 ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73549-006
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
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73549-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
2NDC:73549-006-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
3NDC:73549-006-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
4NDC:73549-006-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
5NDC:73549-006-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
6NDC:73549-006-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
7NDC:73549-006-07480 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
8NDC:73549-006-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
9NDC:73549-006-09750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
10NDC:73549-006-10946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
11NDC:73549-006-11950 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
12NDC:73549-006-122000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
13NDC:73549-006-133785.4 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(73549-006)

Revised: 6/2020
Document Id: a8cf19af-fbff-c102-e053-2a95a90a35af
Set id: a8cf0f99-06ec-2d1b-e053-2a95a90ad4f9
Version: 1
Effective Time: 20200624
 
Fortress Expert Co., Ltd