FDA.reportPublic FDA data

CAL-SHINE ANTISEPTIC HAND SANITIZER

Manufacturer
California Shine Construction
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:13

Label at a glance#

ProductCAL-SHINE ANTISEPTIC HAND SANITIZER
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

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
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf extract, glycerin, hydrogen peroxide, lavender oil, water

Questions? +1-559-412-7402

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 4:00 PM

SPL UNCLASSIFIED SECTION

With Lavender Essential Oils and Aloe vera

Manufactured by:
California Shine Construction & Sanitizing,
3251 N Marks Ave, Fresno, CA 93722

​MADE IN THE U.S.A.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN4
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD4
1039900isopropyl alcohol 75 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78604-646-112024-07-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-232024-07-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-372024-07-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-472024-07-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-602024-07-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-112024-01-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-232024-01-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-372024-01-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-472024-01-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-602024-01-30C16284748780-11030e365-05a2-111a-e063-dadaa90a10e2CAL-SHINE ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78604-646-11CAL-SHINE ANTISEPTIC HAND SANITIZER118 mL in 1 BOTTLELIQUID1184
78604-646-23CAL-SHINE ANTISEPTIC HAND SANITIZER237 mL in 1 BOTTLELIQUID2374
78604-646-37CAL-SHINE ANTISEPTIC HAND SANITIZER3785 mL in 1 BOTTLELIQUID37854
78604-646-47CAL-SHINE ANTISEPTIC HAND SANITIZER474 mL in 1 BOTTLELIQUID4744
78604-646-60CAL-SHINE ANTISEPTIC HAND SANITIZER60 mL in 1 BOTTLELIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78604-646CAL-SHINE ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [CALIFORNIA SHINE CONSTRUCTION]4Legacy NDC, 5 package rows20230113_45489785-2228-4bf7-83c0-9160e357cffc.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78604-64678604-646-60, 78604-646-11, 78604-646-23, 78604-646-47, 78604-646-37

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
ISOPROPYL ALCOHOLND2M416302ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
LAVENDER OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT

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
3f54e374-3eef-4e66-8d52-aace004432c545489785-2228-4bf7-83c0-9160e357cffc2023-01-12WarningsExact identifier
spl id: 3f54e374-3eef-4e66-8d52-aace004432c5
spl set id: 45489785-2228-4bf7-83c0-9160e357cffc

Reported adverse events (FAERS/openFDA)#

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