FDA.reportPublic FDA data

Smart Care Personal Safety Kit

Manufacturer
Ashtel Studios, Inc
Effective date
2021-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:03

Label at a glance#

ProductSmart Care Personal Safety Kit
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

•Hand sanitizer to help reduce bacteria on the skin

Dosage and administration

•Wet hands thoroughly with product and allow to dry. •Discard wipes in trash receptacle after use. Do not flush. •Children under 6 years of age should be supervised by adult when applying this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

•Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

When using this product do not use in or near eyes, ears and mouth.In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears on the skin.

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.
•Discard wipes in trash receptacle after use. Do not flush.
•Children under 6 years of age should be supervised by adult when applying this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua,Phenoxyethanol, Polyaminopropyl biguanide, Glycerin, Propylene Glycol, Benzalkonium Chloride,Ethylhexylglycerin

SPL UNCLASSIFIED SECTION

3x FACE MASKS
3-PLY

3x ANTIBACTERIAL WIPES
Kills Up To 99.9% Of Most Common Germs

3x PAIRS OF VINYL HAND GLOVES
Powder Free
Latex Free

Kit Includes
3 Face Masks • 3 Antibacterial Wipes  • 6 Vinyl Hand Gloves

Face Mask Directions
Place mask over nose and mouth, and place an ear loop around each ear. Pull bottom of mask under chin and mold the nose piece around the nose. The mask should cover face from the nose to underneath the chin. Discard mask after use. One size fits all.

Face Mask Warning
This mask is not a respirator. This product is intended for general purpose infection control practices. When properly worn, masks offer some protection to you, but does not eliminate the risk of contracting any disease or infection. Change mask immediately if splashed with blood or bodily fluids.

Gloves
Storage: Protect from freezing. Avoid excessive heat. Keep dry. Products should be shielded from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. Disposal: Dispose of gloves and all biologically contaminated matter in an appropriate container.

Wipes Warning
This wipe is for external use, not for internal use. Please keep away from children.

MEDICAL USE PROHIBITED
THIS PRODUCT IS A NON-MEDICAL DEVICE FOR CIVIL USE ONLY. 

Smart Care® 
SMARTCAREUS.COM
Designed in USA   •   Made in China

QUESTIONS OR COMMENTS?
1-877-274-8358   TOLL FREE IN U.S.A.
1-909-434-0911   INTERNATIONAL

PATENTS, COPYRIGHTS, AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-072-012024-01-30C16284748780-11030e365-5def-111a-e063-dadaa90a10e2Smart Care ® PERSONAL SAFETY KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-072-01Smart Care Personal Safety Kit3 in 1 BOXCLOTH31
70108-072-01Smart Care Personal Safety Kit1 in 1 PACKETCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-072SMART CARE PERSONAL SAFETY KIT (BENZALKONIUM CHLORIDE) CLOTH [ASHTEL STUDIOS, INC]1Legacy NDC, 2 package rows20210626_43948eb2-d2dd-4b6e-b1ea-f198fef339d5.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-07270108-072-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
f008266f-c308-4e26-9db3-03c42b1a907543948eb2-d2dd-4b6e-b1ea-f198fef339d52021-06-08WarningsExact identifier
spl id: f008266f-c308-4e26-9db3-03c42b1a9075
spl set id: 43948eb2-d2dd-4b6e-b1ea-f198fef339d5

Reported adverse events (FAERS/openFDA)#

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