Curative Biocentric Antiseptic Hand Sanitizer

Manufacturer
Circular Centric, Inc.
Effective date
2020-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:36

Label at a glance#

ProductCurative Biocentric Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

  1. Glycerol (2.00% v/v).
  2. Carbomer Homopolymer Type C (0.30% v/v).
  3. Sterile distilled water or boiled cold water
  4. Fragrance Cucumber (0.004% v/v)
  5. FD&C Blue No. 1 and FD&C Yellow No. 5
  6. Propylene Glycol (0.50% v/v)
  7. Aminonethyl propanol (0.10% v/v)
  8. Vitamin E (0.005% v/v)
  9. Aloe Vera Leaf (0.005% v/v)
  10. Isopropyl Myristate (0.50% v/v)

The firm does not add other active or inactive ingredients than stated above. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product keep out of 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 occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, carbomer, fragrance (parfum),, propylene glycol, aminomethyl propanol, vitamine e, aloe vera leaf, blue no. 1, yellow no. 5 purified water (aqua) USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Curative Biocentric Antiseptic 2oz or 60mLCurative Biocentric Antiseptic 2oz or 60mL

60mL NDC 77094-888-02

Curative Biocentric Antiseptic Hand Sanitizer 8oz or 236mLCurative Biocentric Antiseptic Hand Sanitizer 8oz or 236mL

236mL NDC 77094-888-08

Curative Biocentric Antiseptic Hand Sanitizer 16.9oz or 500 mLCurative Biocentric Antiseptic Hand Sanitizer 16.9oz or 500 mL

500mL NDC 77094-888-16

Curative Biocentric Antiseptic Hand Sanitizer 1gal or 3785mLCurative Biocentric Antiseptic Hand Sanitizer 1gal or 3785mL

3785mL NDC 77094-888-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77094-888-01Curative Biocentric Antiseptic Hand Sanitizer3785 mL in 1 BOTTLE, DISPENSINGGEL37851
77094-888-02Curative Biocentric Antiseptic Hand Sanitizer60 mL in 1 BOTTLE, DISPENSINGGEL601
77094-888-08Curative Biocentric Antiseptic Hand Sanitizer236 mL in 1 BOTTLE, DISPENSINGGEL2361
77094-888-16Curative Biocentric Antiseptic Hand Sanitizer500 mL in 1 BOTTLE, DISPENSINGGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77094-888CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER (ALCOHOL) GEL [CIRCULAR CENTRIC, INC.]1Legacy NDC, 4 package rows20200725_ab35ddfc-c053-91df-e053-2995a90a6782.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
77094-88877094-888-02, 77094-888-08, 77094-888-16, 77094-888-01
78056-888

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
ab35ddfc-c055-91df-e053-2995a90a6782ab35ddfc-c053-91df-e053-2995a90a67822020-07-24WarningsExact identifier
spl id: ab35ddfc-c055-91df-e053-2995a90a6782
spl set id: ab35ddfc-c053-91df-e053-2995a90a6782

Reported adverse events (FAERS/openFDA)#

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