FDA.reportPublic FDA data

Curative Biocentric Antiseptic Hand Sanitizer

Manufacturer
Circular Centric Inc.
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:46

Label at a glance#

ProductCurative Biocentric Antiseptic Hand Sanitizer
Active ingredientALCOHOL
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

Alcohol 80% 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

  • on 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 or 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 INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, water

OTC - QUESTIONS SECTION

Questions? +1- 949-355-5353

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

  • ALCOHOL ANTISEPTIC
  • TOPICAL SOLUTION

www.Curative.us

Distributed by: Agro Spect, 12080 Magnolia Ave, Riverside, CA 92503

SCAN FOR PROMO

BLOCKCHAIN TRACEABILITY

MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77094-200-082022-01-28C16284748780-1d6a99b39-3f3f-a426-e053-dadaa90af4c2Curative TM BIOCENTRIC ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77094-200-08Curative Biocentric Antiseptic Hand Sanitizer3800 mL in 1 BOTTLESOLUTION38001
77094-200-08Curative Biocentric Antiseptic Hand Sanitizer1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77094-200CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER (ALCOHOL) SOLUTION [CIRCULAR CENTRIC INC.]1Legacy NDC, 2 package rows20200609_fd2b6ba1-3a8e-4ded-bf93-a82761bf541e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77094-20077094-200-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
71db51c6-1820-4a87-89a7-a659ae197a27fd2b6ba1-3a8e-4ded-bf93-a82761bf541e2020-05-29WarningsExact identifier
spl id: 71db51c6-1820-4a87-89a7-a659ae197a27
spl set id: fd2b6ba1-3a8e-4ded-bf93-a82761bf541e

Reported adverse events (FAERS/openFDA)#

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