Sani Gel by The Joe Sani Company

Sani Gel by

Drug Labeling and Warnings

Sani Gel by is a Otc medication manufactured, distributed, or labeled by The Joe Sani Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANI GEL- alcohol gel 
The Joe Sani Company

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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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) consistent with World Health Organization (WHO) recommendations:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

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

Water, Carbomer, Triethanolamine, Lemongrass oil

Package Label - Principal Display Panel

378 mL NDC: 80685-429-37

SANI GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80685-0429
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
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)	0.1 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36)	0.5 mL  in 100 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80685-0429-3	3785 mL in 1 JUG; Type 0: Not a Combination Product	10/16/2020	10/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/16/2020	10/14/2022

Labeler - The Joe Sani Company (117678428)

Establishment
Name	Address	ID/FEI	Business Operations
The Joe Sani Company		117678428	relabel(80685-0429)

Revised: 10/2020

Document Id: b0dc73b6-ba98-be41-e053-2995a90af54f

34390-5

Set id: b0dc73b6-baa6-be41-e053-2995a90af54f

Version: 1

Effective Time: 20201004