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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008 HAND SANITIZER

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination on contact

Recommended for repeated use

Warnings

Flammable, keep away from open flame and sources of heat

External use only

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

Keep out of reach of children

If swallowed, call a poison control center or get medical help right away .

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

Store below 105F(41C)

May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance

PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)

Package Label Principal Display Panel

1234

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73549-008
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73549-008-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
2NDC:73549-008-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
3NDC:73549-008-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
4NDC:73549-008-041800 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/23/2020
Labeler - Fortress Expert Co., Ltd (543358697)
Registrant - Fortress Expert Co., Ltd (543358697)
Establishment
NameAddressID/FEIBusiness Operations
Fortress Expert Co., Ltd543358697manufacture(73549-008)

Revised: 7/2020
Document Id: ab1d8069-2c4f-056c-e053-2a95a90acf2e
Set id: ab1d8069-2c4e-056c-e053-2a95a90acf2e
Version: 1
Effective Time: 20200723
 
Fortress Expert Co., Ltd