CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER- alcohol gel 
Circular Centric, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Curative Biocentric Antiseptic Hand Sanitizer

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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

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.

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.

Directions

Other information

Inactive ingredients

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

Curative Biocentric Antiseptic 2oz or 60mL

60mL NDC 77094-888-02

Curative Biocentric Antiseptic Hand Sanitizer 8oz or 236mL

236mL NDC 77094-888-08

Curative Biocentric Antiseptic Hand Sanitizer 16.9oz or 500 mL

500mL NDC 77094-888-16

Curative Biocentric Antiseptic Hand Sanitizer 1gal or 3785mL

3785mL NDC 77094-888-01

CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77094-888(NDC:78056-888)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.5 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.005 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.005 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00001 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.00001 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77094-888-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
2NDC:77094-888-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
3NDC:77094-888-16500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
4NDC:77094-888-013785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/24/2020
Labeler - Circular Centric, Inc. (117507693)
Registrant - Circular Centric, Inc. (117507693)

Revised: 7/2020
Document Id: ab35ddfc-c055-91df-e053-2995a90a6782
Set id: ab35ddfc-c053-91df-e053-2995a90a6782
Version: 1
Effective Time: 20200724
 
Circular Centric, Inc.