CALI DISTILLERY GEL HAND SANITIZER- alcohol gel 
CALI Distillery

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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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) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70 to 72%, 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. Glycerol (1.45% v/v).
  3. Carbomer
  4. 85% triethanolamine
  5. Propylene glycol
  6. Sterile distilled water or boiled cold water.

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 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 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 to gel, triethanolamine for PH balance, Propylene Glycol, Citrus oil, purified water USP

Package Label - Principal Display Panel

474 mL NDC: 74500-0004-1 front label

front label

474 mL NDC: 74500-0004-1 back label

back label

1 gallon NDC: 74500-0004-5 front label 1 gallon front label

32 oz label

32 oz label

gallon NDC: 74500-0004-5 back label

hand sanitizer back label

remade 8 ounce remade 8 ounce

spectrum private label 8 ounce

remade 1 gal

CALI DISTILLERY GEL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74500-0004
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74500-0004-1474 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
2NDC:74500-0004-2237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
3NDC:74500-0004-3946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
4NDC:74500-0004-41893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
5NDC:74500-0004-53786 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - CALI Distillery (091173262)
Establishment
NameAddressID/FEIBusiness Operations
Cali Distillery091173262manufacture(74500-0004)

Revised: 1/2022
Document Id: d571365d-63f0-1369-e053-2995a90aed20
Set id: a57f22da-41d9-4ae3-e053-2995a90a9db4
Version: 6
Effective Time: 20220113
 
CALI Distillery