FDA.reportPublic FDA data

GENTLECARE HAND AND SKIN SANITIZER

Manufacturer
PARAGON SOLUTIONS US, INC. | Lifequest Creations LLC
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:25:49

Label at a glance#

ProductGENTLECARE HAND AND SKIN SANITIZER
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride, 0.13%

OTC - PURPOSE SECTION

Purpose

Antibacterial

INDICATIONS & USAGE SECTION

Uses
■ For sanitizing to reduce bacteria on the skin.

WARNINGS SECTION

Warnings
For external use only
When using this product■ Avoid contact with
eyes. ■ In case of eye contact, flush with water.
■ Call doctor if irritation persists.

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.

DOSAGE & ADMINISTRATION SECTION

Directions
■ Apply 1 - 2 pump to dry hands, rub into skin.
■ Supervise children in the use of this product.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Purified Water, Aloe Vera, Propylene Glycol,
Triethylene Glycol, Polysorbate-20.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GentleCare

Solutions

Foaming

Hand & Skin
Sanitizer

  • Kills 99.99% of Germs
  • Moisturizes & Conditions
  • Alcohol Free, Sting Free
  • Fragrance Free

with Aloe Vera
1.7 fl. oz. (50 mL)

Sold by:

GentleCare
Solutions

A division of:
Paragon Solutions US, Inc.
New Hill, NC 27562

www.gentlecare.us

Questions?

Call Us Toll Free

1.800.262.8670
Monday to Friday
9:00 am to 4:00 pm EST

1.7 FL OZ

020-02020-02

7.5 FL OZ

020-07020-07

16.5 FL OZ

020-18020-18

1 GAL

020-28020-28

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN8
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD8
1020365benzalkonium chloride 0.13 % Topical FoamSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130800178020028GTIN-13: 0800178020028
EAN-13: 0800178020028
GTIN-12: 800178020028
UPC-A: 800178020028
GTIN storage (14 digits): 00800178020028		020-02.jpg
BarcodeEAN-130800178020073GTIN-13: 0800178020073
EAN-13: 0800178020073
GTIN-12: 800178020073
UPC-A: 800178020073
GTIN storage (14 digits): 00800178020073		020-07.jpg
BarcodeEAN-130800178020189GTIN-13: 0800178020189
EAN-13: 0800178020189
GTIN-12: 800178020189
UPC-A: 800178020189
GTIN storage (14 digits): 00800178020189		020-18.jpg
BarcodeEAN-130800178020288GTIN-13: 0800178020288
EAN-13: 0800178020288
GTIN-12: 800178020288
UPC-A: 800178020288
GTIN storage (14 digits): 00800178020288		020 28.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78181-020-02GENTLECARE HAND AND SKIN SANITIZER50 mL in 1 BOTTLE, PUMPLIQUID508
78181-020-07GENTLECARE HAND AND SKIN SANITIZER221 mL in 1 BOTTLE, PUMPLIQUID2218
78181-020-18GENTLECARE HAND AND SKIN SANITIZER550 mL in 1 BOTTLE, PUMPLIQUID5508
78181-020-28GENTLECARE HAND AND SKIN SANITIZER3785 mL in 1 JUGLIQUID37858

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78181-02078181-020-02, 78181-020-07, 78181-020-18, 78181-020-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA FLOWER575DY8C1ERIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIETHYLENE GLYCOL3P5SU53360IACT
POLYSORBATE 207T1F30V5YHIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

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
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
ndc (package): 78181-020-18
ndc (package): 78181-020-02
ndc (package): 78181-020-07
ndc (package): 78181-020-28
ndc (product): 78181-020
ndc11 (package): 78181002018
ndc11 (package): 78181002028
ndc11 (package): 78181002002
ndc11 (package): 78181002007
spl id: 46181bb4-3d7b-f7cc-e063-6394a90a3033
spl set id: 16650277-fa62-485e-9a82-7763d2b50168

Reported adverse events (FAERS/openFDA)#

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