CleanFreak 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 gel 
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

Hand Sanitizer

Outrageous Orange

Acstive ingredient                     Purpose

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

Purpose

Antiseptic

Uses

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  water, poly acrylic acid, aloe vera leaf, hydrogen peroxide, limonene

CLEANFREAK 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90026-011
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90026-011-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
2	NDC: 90026-011-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
3	NDC: 90026-011-90	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
4	NDC: 90026-011-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
5	NDC: 90026-011-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
6	NDC: 90026-011-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020

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(90026-011) , pack(90026-011) , label(90026-011)

Revised: 4/2022

Document Id: ddb9934b-6d54-5c07-e053-2a95a90a29e7

34390-5

Set id: c201c1c6-cec0-434b-b7b1-e1488b80aed4

Version: 5

Effective Time: 20220428