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.

----------

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)

Principal Display Panel

HELLO HAND SANITIZER - FRESH MINT AND TEA TREE OIL 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55882-6109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM PIDOLATE (UNII: 1V74VH163T)  
WATER (UNII: 059QF0KO0R)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55882-6109-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/01/202003/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/202003/31/2022
Labeler - Hello Products LLC (040714890)
Registrant - MYKU Biosciences LLC (106728135)
Establishment
NameAddressID/FEIBusiness Operations
MYKU Biosciences LLC106728135manufacture(55882-6109)

Revised: 3/2022
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.