Cali Distillery Gel Hand Sanitizer: Package Insert and Label Information

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.

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.

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

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

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

  • 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

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

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
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474 mL NDC: 74500-0004-1 back label

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

1 gallon front label
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32 oz label

32 oz label
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gallon NDC: 74500-0004-5 back label

hand sanitizer back label
(click image for full-size original)

remade 8 ounce

remade 8 ounce
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spectrum private label 8 ounce
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remade 1 gal
(click image for full-size original)
CALI DISTILLERY GEL HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74500-0004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL 2 mL in 100 mL
TROLAMINE 0.1 mL in 100 mL
CARBOMER 940 0.5 mL in 100 mL
GLYCERIN 1.45 mL in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74500-0004-1 474 mL in 1 BOTTLE, DISPENSING None
2 NDC:74500-0004-2 237 mL in 1 BOTTLE, PUMP None
3 NDC:74500-0004-3 946 mL in 1 BOTTLE, PUMP None
4 NDC:74500-0004-4 1893 mL in 1 BOTTLE, PUMP None
5 NDC:74500-0004-5 3786 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — CALI Distillery (091173262)
Establishment
Name Address ID/FEI Operations
Cali Distillery 091173262 manufacture (74500-0004)

Revised: 01/2022 CALI Distillery

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