KLEAN 4 IN 1 SANITIZER- alcohol gel 
DepilatoCosmetics SAS

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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Hand Sanitizer

Active Ingredient(s)

Alcohol 80,16 % v/v Denatured Alcohol. 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

Purified Water - Propylene Glycol - Acrylates / C10-30 Alkyl Acrylate Crosspolymer - Methyl Gluceth-20 - Polyglyceryl-3-Laurate

Package Label - Principal Display Panel

0.5 kg (500 g) NDC: 82122-002-01 image description

KLEAN 4 IN 1 SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82122-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL430 g  in 500 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 1.75 g  in 500 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3.40 g  in 500 g
WATER (UNII: 059QF0KO0R) 61.83 g  in 500 g
METHYL GLUCETH-20 (UNII: J3QD0LD11P) 1.25 g  in 500 g
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E) 1.25 g  in 500 g
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.527 g  in 500 g
2-AMINO-1-BUTANOL (UNII: N008Q02GPS) 0.003 g  in 500 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82122-002-01500 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/14/2021
Labeler - DepilatoCosmetics SAS (275215360)
Establishment
NameAddressID/FEIBusiness Operations
DepilatoCosmetics SAS275215360manufacture(82122-002)

Revised: 12/2021
Document Id: 84ce81db-99e2-40e5-903d-12adc035e92b
Set id: ccf04e17-3d65-4ab5-a2c5-d2a9cc5008cd
Version: 1
Effective Time: 20211214
 
DepilatoCosmetics SAS