HAND SANITIZER- alcohol gel 
Fareva Morton Grove, 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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  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin
  3. Fragrance
  4. Sterile distilled water or boiled cold water.
  5. Acrylates/C10-30 Alkyl Acrylate Crosspolymer
  6. Butylene Glycol
  7. Aloe Barbadensis Leaf Juice
  8. Aminomethyl Propanol
  9. Titanium Dioxide
  10. 1,2-Hexanediol
  11. Agar
  12. Gellan Gum
  13. Calcium Alginate
  14. Ultramarines
  15. Phenoxyethanol
  16. Propylene Glycol
  17. Citric Acid
  18. Sodium Benzoate
  19. Potassium Sorbate

Active Ingredient(s)

Alcohol 77% 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 heat 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 and redness develops and persists.

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

Directions

Other information

Inactive ingredients

1,2-Hexanediol, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Agar, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylene Glycol, Calcium Alginate, Citric Acid, Fragrance (Parfum), Gellan Gum, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Titanium Dioxide (CI 77891), Ultramarines (CI 77007), Water (Aqua)

Package Label - Principal Display Panel

50 mL NDC: 72686-184-05

GARDENIA

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72686-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
CALCIUM ALGINATE (UNII: 8P20S56HZI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72686-184-0550 mL in 1 TUBE; Type 0: Not a Combination Product11/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/03/2020
Labeler - Fareva Morton Grove, Inc. (116752326)
Establishment
NameAddressID/FEIBusiness Operations
Fareva Morton Grove, Inc.116752326manufacture(72686-184) , analysis(72686-184) , label(72686-184) , pack(72686-184) , relabel(72686-184) , repack(72686-184)

Revised: 11/2020
Document Id: b3399bd5-8977-30fe-e053-2995a90a3b60
Set id: b339ae8e-8a8b-e70b-e053-2995a90aa9e0
Version: 1
Effective Time: 20201103
 
Fareva Morton Grove, Inc.