CleanFreak Foaming Hand Sanitizer Outrageous Orange

CleanFreak by

Drug Labeling and Warnings

CleanFreak by is a Otc medication manufactured, distributed, or labeled by Sanitizer Supply, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEANFREAK- alcohol solution 
Sanitizer Supply, 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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CleanFreak

Foaming Hand Sanitizer

Outrageous Orange

Acstive ingredient                     Purpose

Ethyl Alcohol 80% v/v ............Antiseptic

Purpose

Antiseptic

Use[s]

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.

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  aloe, dimethicone peg-10 phosphate, purified water USP, limonene

CLEANFREAK 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90026-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90026-021-90	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
2	NDC: 90026-021-98	1040988 mL in 1 DRUM; Type 0: Not a Combination Product	11/09/2020
3	NDC: 90026-021-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/08/2020	04/27/2022

Labeler - Sanitizer Supply, LLC (117594299)

Establishment
Name	Address	ID/FEI	Business Operations
Sanitizer Supply, LLC		117594299	manufacture(90026-021) , pack(90026-021) , label(90026-021)

Revised: 4/2022

Document Id: ddb9eee1-a9a4-a20d-e053-2995a90a58c8

34390-5

Set id: e63e86dc-5efb-4766-9ccc-d49cb110fce7

Version: 3

Effective Time: 20220428