FDA.reportPublic FDA data

Smart Care HAND SANITIZER

Manufacturer
Ashtel Studios, Inc
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:16

Label at a glance#

ProductSmart Care HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

​ ​Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Storage and handling

​• Do not store above 100° F (38°C) • May discolor some fabrics. • Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

​​To help reduce bacteria and germs on the skin.

Warnings:

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame.

When using this product

• Keep out of eyes.

• In case of contact with eyes, flush thoroughly with water.

• Avoid contact with broken skin.

• Do not inhale or ingest.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

​​Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Other Information:

STORAGE AND HANDLING SECTION

​• Do not store above 100° F (38°C)

• May discolor some fabrics.

• Harmful to wood finishes and plastics.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), FD&C Yellow No.5, FD&C Blue No.1.

SPL UNCLASSIFIED SECTION

KILLS UP TO 99.99% OF MOST COMMON GERMS

Aloe Vera & Vitamin E

FAST & EFFECTIVE

Keep bottle of Hand Sanitizer in:

  • Automobile
  • Bathrooms
  • Workplace
  • Kitchen
  • Medical Offices
  • Nurseries

SMARTCAREUS.COM

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

DESIGNED IN U.S.A.

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sntzr56Sntzr56

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-056-012024-01-30C16284748780-11030e365-1ace-111a-e063-dadaa90a10e2Smart Care ® Hand SANITIZER
70108-056-022024-01-30C16284748780-11030e365-1ace-111a-e063-dadaa90a10e2Smart Care ® Hand SANITIZER
70108-056-032024-01-30C16284748780-11030e365-1ace-111a-e063-dadaa90a10e2Smart Care ® Hand SANITIZER
70108-056-042024-01-30C16284748780-11030e365-1ace-111a-e063-dadaa90a10e2Smart Care ® Hand SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-056-01Smart Care HAND SANITIZER59 mL in 1 BOTTLEGEL591
70108-056-02Smart Care HAND SANITIZER236.6 mL in 1 BOTTLEGEL236.61
70108-056-03Smart Care HAND SANITIZER500 mL in 1 BOTTLEGEL5001
70108-056-04Smart Care HAND SANITIZER1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-056SMART CARE HAND SANITIZER (ETHYL ALCOHOL) GEL [ASHTEL STUDIOS, INC]1Legacy NDC, 4 package rows20200612_1a1a4db4-6513-409b-abbd-a6d42c4c4946.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-05670108-056-01, 70108-056-02, 70108-056-03, 70108-056-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
cecc4487-0e7e-48fb-8227-2514ace575b71a1a4db4-6513-409b-abbd-a6d42c4c49462020-06-09WarningsExact identifier
spl id: cecc4487-0e7e-48fb-8227-2514ace575b7
spl set id: 1a1a4db4-6513-409b-abbd-a6d42c4c4946

Reported adverse events (FAERS/openFDA)#

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