SERENE CLEAN AND PURE HAND SANITIZER GEL- ethanol gel 
Serene Clean & Pure LLC

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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Serene Clean & Pure Ethanol Gel Hand Sanitizer

Active ingredient

Ethyl Alcohol 65% v/v.

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

Other information

Inactive ingredients

Water, glycerin, carbomer, aloe

Package Label - Principal Display Panel

Serene Clean & Pure

Be Wise & Sanitize

Gel Hand Sanitizer

www.serenepure.com

(424) 329-2515

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

Manufactured by:

CALIFORNIA CHEMICAL

(424) 292-3424

Costa Mesa, CA 92626

www.calichemical.com

Front label

SERENE CLEAN AND PURE HAND SANITIZER GEL 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78643-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78643-300-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/05/2020
Labeler - Serene Clean & Pure LLC (117539963)
Registrant - Serene Clean & Pure LLC (117539963)

Revised: 1/2021
Document Id: b82d4cdc-3466-6221-e053-2a95a90ae868
Set id: b82d40b0-3a6b-4227-e053-2995a90adfac
Version: 1
Effective Time: 20210101
 
Serene Clean & Pure LLC