f(x)l Skin Care Hand Sanitizer

Manufacturer
G.S. COSMECEUTICAL USA, INC.
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:26

Label at a glance#

Productf(x)l Skin Care Hand Sanitizer
Active ingredientAlcohol
Label structure10 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to reduce the germs on skin

Warnings

WARNINGS SECTION

For external use only.

SPL UNCLASSIFIED SECTION

Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aminomethyl Propanol, Aqua (Water), Carbomer, Glycerin

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65113-1001-1f(x)l Skin Care Hand Sanitizer118 mL in 1 BOTTLEGEL1182
65113-1001-2f(x)l Skin Care Hand Sanitizer237 mL in 1 BOTTLEGEL2372
65113-1001-3f(x)l Skin Care Hand Sanitizer473 mL in 1 BOTTLEGEL4732
65113-1001-4f(x)l Skin Care Hand Sanitizer946 mL in 1 BOTTLEGEL9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-1001F(X)L SKIN CARE HAND SANITIZER (ALCOHOL) GEL [G.S. COSMECEUTICAL USA, INC.]2Legacy NDC, 4 package rows20220107_7023eea3-cedd-462d-a718-b2277c16b6b6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65113-100165113-1001-1, 65113-1001-2, 65113-1001-3, 65113-1001-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d8f5d967-901c-447f-9436-54ef4b29b3177023eea3-cedd-462d-a718-b2277c16b6b62022-01-06WarningsExact identifier
spl id: d8f5d967-901c-447f-9436-54ef4b29b317
spl set id: 7023eea3-cedd-462d-a718-b2277c16b6b6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.