F(X)L SKIN CARE HAND SANITIZER- alcohol gel 
G.S. COSMECEUTICAL USA, INC.

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.

----------

f(x)l™ Skin Care Hand Sanitizer

Drug Facts

Active Ingredient

Ethanol 70% v/v

Purpose

Antiseptic

Use

Hand sanitizer to reduce the germs on skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product

  • keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.
  • do not inhale or ingest.

Stop use and ask a doctor if irritation or rash occurs and lasts.

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

Directions

Other Information

Inactive Ingredients

Aminomethyl Propanol, Aqua (Water), Carbomer, Glycerin

Distributed by:
G.S. Cosmeceutical USA, Inc.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

f(x)l™
skincare

Hand Sanitizer

Kills 99.9% of Germs

Unscented Gel

16 FL OZ / 473 mL

Principal Display Panel - 473 mL Bottle Label
F(X)L SKIN CARE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Semuloparin (UNII: 4QW4AN84NQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65113-1001-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
2NDC:65113-1001-2237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
3NDC:65113-1001-3473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
4NDC:65113-1001-4946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A05/15/2020
Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(65113-1001)

Revised: 1/2022
Document Id: d8f5d967-901c-447f-9436-54ef4b29b317
Set id: 7023eea3-cedd-462d-a718-b2277c16b6b6
Version: 2
Effective Time: 20220106
 
G.S. COSMECEUTICAL USA, INC.