MELLENUSA STUDIO (as PLD) - HAND SANITIZER (82174-201) - DELIST

HELLO SPORT HAND SANITIZER by

Drug Labeling and Warnings

HELLO SPORT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by MELLENUSA STUDIO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELLO SPORT HAND SANITIZER 70 PERCENT- ethyl alcohol spray 
MELLENUSA STUDIO, LLC

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MELLENUSA STUDIO (as PLD) - HAND SANITIZER (82174-201) - DELIST

ACTIVE INGREDIENTS

Ethyl alcohol 70% V/V

PURPOSE

ANTIMICROBIAL

USES

to help reduce bacteria on the skin. For use when soap and water are not available.

WARNINGS

For external use onlyDo not take it internally. Use with

caution to people who are allergic to alcohol

Flammable, Keep away from fire or flame

Stop use and consult physicianif irritation or rash occurs.

These may be signs of a serious condition.

Do not use

• in children less than 2 months of age
• on open skin wounds

Keep out of reach of eyes, ears, and mouth. in case of contact with eyes, rinse eyes throroughly 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

DIRECTIONS

• Take an appropriate amount (2-3ml) of the product to moisten your hands and rub for 15 seconds until the liquid covers your hands, wait for drying, and do not wash with water.
• Supervise children under 6 years of age when using this product to avoid swallowing.

INACTIVE INGREDIENTS

GRAPEFRUIT:Water, Glycerin, Polysorbate 20, Allantoin, Panthenol, Citrus Limon (Lemon) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil

COCONUT:Water, Glycerin, Polysorbate 20, Allantoin, Panthenol, Fragrance

LAVENDER EUCALYPTUS:Water, Glycerin, Polysorbate 20, Allantoin, Panthenol, Lavandula Angustifolia (Lavender) Oil, Eucalyptus Globulus (Eucalyptus) Leaf Oil

Other Information

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

HELLO SPORT HAND SANITIZER  70 PERCENT
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82174-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ORANGE PEEL (UNII: TI9T76XD44)
EUCALYPTUS OIL (UNII: 2R04ONI662)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
GRAPEFRUIT OIL (UNII: YR377U58W9)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82174-201-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/24/2023	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/24/2023	12/31/2023

Labeler - MELLENUSA STUDIO, LLC (080951813)

Revised: 3/2024

Document Id: 14bc2d6c-9443-a027-e063-6294a90a66a5

34390-5

Set id: fc7e32c5-e828-65ef-e053-6394a90abd84

Version: 2

Effective Time: 20240328