MedPath

CaseysLavender

Caseys Hand Soap

Approved
Approval ID

b5bc8770-13ef-36dc-e053-2995a90a3f51

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

KYNC Design LLC

DUNS: 039933298

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Caseys Hand Soap Lavender Scent

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76557-051
Application NumberM014
Product Classification
M
Marketing Category
C200263
G
Generic Name
Caseys Hand Soap Lavender Scent
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (15)

LAVANDULA ANGUSTIFOLIA FLOWERInactive
Code: 19AH1RAF4M
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
COCAMIDOPROPYLAMINE OXIDEInactive
Code: M4SL82J7HK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM NITRATEInactive
Code: 77CBG3UN78
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 g
Code: F5UM2KM3W7
Classification: ACTIB
PEG-4 RAPESEEDAMIDEInactive
Code: 89575CN928
Classification: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)Inactive
Code: 5Z4DPO246A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2023

PRODUCT LABELS

Caseys1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/15/2020

Use

Helps eliminate bacteria on hands

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/28/2020

Active Ingredient(s)

Benzalkonium Chloride (CAS NO: 68424-85-1), 0.13% .

Purpose

Antimicrobial

WARNINGS SECTION

LOINC: 34071-1Updated: 3/28/2020

WARNINGS

For external use only.

Do not use

If you are allergic to any of the ingredients.

Stop use and ask a doctor

if irritation or rash occurs.

Do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/28/2020

Directions

Wash hands and rinse

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/28/2020

Inactive ingredients

Water, Anhydrous Citric Acid, Cocamidopropylamine Oxide, Edetate Sodium, Fragrance, Glycerin, Lauramine Oxide, Magnesium Chloride, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-120 Methyl Glucose Dioleate, PEG-4 Rapeseedamide, Styrene/acrylamide Copolymer (mw 500000), Colorant CI 60725, Lavandula Angustifola Extract.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2023

Antibacterial

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CaseysLavender - FDA Drug Approval Details