Hello® hand sanitizer spray - aloe + sea minerals

Hello hand sanitizer - aloe and sea minerals by

Drug Labeling and Warnings

Hello hand sanitizer - aloe and sea minerals by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC, Myku Biosciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELLO HAND SANITIZER - ALOE AND SEA MINERALS- 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 spray - aloe + sea minerals

Drug Facts

Active ingredient(s)

Ethyl alcohol 62%

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. Do not spray toward face.

Flammable. Keep away from heat or flame.

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.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

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

Directions

• Spray enough product on hands to cover all surfaces
• Rub hands together until dry
• Supervise children under 6 years of age.

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

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

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

naturally
friendly™
hello®

antibacterial
hand sanitizer spray

never tested
on animals

with natural
fragrance

aloe + sea minerals

2 FL OZ/59mL

HELLO HAND SANITIZER - ALOE AND SEA MINERALS 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6111
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
WATER (UNII: 059QF0KO0R)
SODIUM PIDOLATE (UNII: 1V74VH163T)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6111-1	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/01/2020	03/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	12/01/2020	03/03/2023

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Myku Biosciences		106728135	MANUFACTURE(55882-6111)

Revised: 11/2020

Document Id: 4d55c51d-290d-4090-838d-82137a0d5ec9

34390-5

Set id: 68678a3c-cf3b-43b4-ad3b-caa952ab4134

Version: 3

Effective Time: 20201130