Label: CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 77094-888-01, 77094-888-02, 77094-888-08, 77094-888-16 - Packager: Circular Centric, Inc.
- This is a repackaged label.
- Source NDC Code(s): 78056-888
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 24, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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.
- Glycerol (2.00% v/v).
- Carbomer Homopolymer Type C (0.30% v/v).
- Sterile distilled water or boiled cold water
- Fragrance Cucumber (0.004% v/v)
- FD&C Blue No. 1 and FD&C Yellow No. 5
- Propylene Glycol (0.50% v/v)
- Aminonethyl propanol (0.10% v/v)
- Vitamin E (0.005% v/v)
- Aloe Vera Leaf (0.005% v/v)
- 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)
- Purpose
- Use
- Warnings
- Do not use
-
WHEN USING
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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77094-888(NDC:78056-888) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:77094-888-02 60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/24/2020 2 NDC:77094-888-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/24/2020 3 NDC:77094-888-16 500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/24/2020 4 NDC:77094-888-01 3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/24/2020 Labeler - Circular Centric, Inc. (117507693) Registrant - Circular Centric, Inc. (117507693)