Cleanslate Hand Sanitizer

Cleanslate Hand Sanitizer by

Drug Labeling and Warnings

Cleanslate Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cleanslate Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEANSLATE HAND SANITIZER- ethanol liquid 
Cleanslate Group 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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Cleanslate Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• apply liberally to hands to cover all surfaces, including the area under the fingernails
• rub hands together until dry

Inactive Ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG-10 dimethicone, phenoxyethanol, polyethylene oxide 600000, polyquaternium 10, water.

MFD FOR CLEANSLATE GROUP LLC

1420 EAST LINDEN AVENUE

LINDEN, NJ 07036

cleanslate

HAND SANITIZER

ALCOHOL 70%

33.8 fl. oz. (1000mL)

CLEANSLATE HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80586-212
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80586-212-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/17/2021	03/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/17/2021	03/31/2023

Labeler - Cleanslate Group LLC (117657934)

Revised: 2/2023

Document Id: f51648c1-1d55-edf8-e053-2a95a90ac881

34390-5

Set id: d102cd71-a891-c8d6-e053-2a95a90aff3f

Version: 2

Effective Time: 20230219