Citrus Mint Hand Sanitizing Spray

Wicked Cleen Hand Sanitizer by

Drug Labeling and Warnings

Wicked Cleen Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Neo-H2, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WICKED CLEEN HAND SANITIZER- isopropyl alcohol spray 
Neo-H2, 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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Citrus Mint Hand Sanitizing Spray

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. 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

• 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.

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

glycerin, hydrogen peroxide, purified water USP, aloe vera leaf liquid, citrus sinensis fruit oil, mentha piperita

Package Label - Principal Display Panel

000 ml NDC: 00000-000-00

WICKED CLEEN HAND SANITIZER 
isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80667-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	7.0275 mL  in 100 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9)	0.014 mL  in 100 mL
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)	0.028 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	16.3555 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80667-003-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/16/2020
2	NDC: 80667-003-16	473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/16/2020	07/09/2021

Labeler - Neo-H2, LLC (117001277)

Registrant - Neo-H2, LLC (117001277)

Establishment
Name	Address	ID/FEI	Business Operations
Neo-H2, LLC		117001277	manufacture(80667-003)

Revised: 8/2021

Document Id: c9261c7f-9f93-6476-e053-2a95a90a0e93

34390-5

Set id: b1931ca5-4ccf-46d2-e053-2a95a90a1b9e

Version: 2

Effective Time: 20210809