F(X)L SKIN CARE HAND SANITIZER- alcohol gel

f(x)l Skin Care Hand Sanitizer by

Drug Labeling and Warnings

f(x)l Skin Care Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use only under adult supervision

Other Information

• do not store above 104° F (40° C)
• may discolor certain fabrics or surfaces

Inactive Ingredients

Aminomethyl Propanol, Aqua (Water), Carbomer, Glycerin

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

F(X)L SKIN CARE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65113-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Semuloparin (UNII: 4QW4AN84NQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65113-1001-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
2	NDC: 65113-1001-2	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
3	NDC: 65113-1001-3	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
4	NDC: 65113-1001-4	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	05/15/2020

Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(65113-1001)