Hello hand sanitizer - fresh mint and tea tree oil

Hello hand sanitizer - fresh mint and tea tree oil by

Drug Labeling and Warnings

Hello hand sanitizer - fresh mint and tea tree oil by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC, MYKU Biosciences LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELLO HAND SANITIZER - FRESH MINT AND TEA TREE OIL- alcohol spray 
Hello Products 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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Hello hand sanitizer - fresh mint and tea tree oil

Active Ingredient(s) Purpose

Ethyl Alcohol 62%...............................................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. Do not spray towards face. Flammable. Keep away from heat or flame.

Stop use and ask a doctor

if irritation or rash occurs.

Do not use

in children less than 2 months of age or 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Inactive ingredients

Water, Triethyl Citrate, Sodium L-pyroglutamate, Fragrance, Aloe Vera Juice, Mixed Tocopherols, Potassium Sorbate, Sodium Benzoate

Other Information

• Store between 15-30ºC (59-86ºF)
• Avoid freezing and excessive heat above 40ºC (104ºF)

HELLO HAND SANITIZER - FRESH MINT AND TEA TREE OIL 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM PIDOLATE (UNII: 1V74VH163T)
WATER (UNII: 059QF0KO0R)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6109-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/01/2020	03/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2020	03/31/2022

Labeler - Hello Products LLC (040714890)

Registrant - MYKU Biosciences LLC (106728135)

Establishment
Name	Address	ID/FEI	Business Operations
MYKU Biosciences LLC		106728135	manufacture(55882-6109)

Revised: 3/2022

Document Id: d92f2ce4-9824-6be2-e053-2a95a90afddf

34390-5

Set id: ba4a8fa2-4da6-0803-e053-2995a90a0a97

Version: 3

Effective Time: 20220301