SERENE CLEAN AND PURE HAND SANITIZER GEL- isopropyl alcohol gel

Serene Clean and Pure Hand Sanitizer Gel by

Drug Labeling and Warnings

Serene Clean and Pure Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Serene Clean & Pure LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

• in 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.

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, glycerin

Package Label - Principal Display Panel

Serene Clean & Pure

Kills 99.9% of All Germs & Bacteria

Gel Hand Sanitizer

70% Isopropyl Alcohol

www.serenepure.com

ABOUT

Serene Clean & Pure is a family owned company that believes in honest and helpful products.

Serene Clean & Pure is a quickly drying hand sanitizer that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life

Distributed by:

Serene Clean & Pure

555 Anton Blvd. Suite 105

Costa Mesa, CA 92626

2 fl. oz.

4 fl. oz.

8 fl. oz.

10 fl. oz.

16 fl. oz.

INGREDIENTS AND APPEARANCE

SERENE CLEAN AND PURE HAND SANITIZER GEL 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78643-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78643-110-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
2	NDC: 78643-110-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
3	NDC: 78643-110-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
4	NDC: 78643-110-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
5	NDC: 78643-110-16	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
6	NDC: 78643-110-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/08/2020

Labeler - Serene Clean & Pure LLC (117539963)

Registrant - Serene Clean & Pure LLC (117539963)