HYGIENIGEL- hand sanitizer solution, gel forming / drops

Hygienigel by

Drug Labeling and Warnings

Hygienigel by is a Otc medication manufactured, distributed, or labeled by HAIKOWER S.r.l., MELCHIONNA PLLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Admin

Place enough HYGIENIGEL on your hands and rub them until dry.

Children under 6 years of age must be supervised when using HYGIENIGEL.

Inactive Ingredients

Water, Melaleuca Alternifolia Leaf Oil, Chlorhexidine Digluconate, Grlycerin, BEnzalkonium Chloride

OTC - Active ingredient

Ethyl Alcohol 75% v/v

OTC - Ask Doctor section

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - Do not use

When using this product, do not ingest, inhale or use in or near the eyes. In case of contact, rinse thoroughly with water for at least 2 minutes.

OTC - Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact the Poison Control Center right away.

OTC - Purpose

Uses Hand Sanitizer to help reduce bacteria on the skin

Indication and usage

Uses Hand Sanitizer to help reduce bacteria on the skin

OTC _ Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

When using this product, do not ingest, inhale or use in or near the eyes. In case of contact, rinse thoroughly with water for at least 2 minutes.

Warnings

- Flammable.

- Keep away from flame and fire.

- For external use only.

Package and Label

INGREDIENTS AND APPEARANCE

HYGIENIGEL 
hand sanitizer solution, gel forming / drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78619-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78619-100-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/26/2021

Labeler - HAIKOWER S.r.l. (433503760)

Registrant - MELCHIONNA PLLC (039407173)

Establishment
Name	Address	ID/FEI	Business Operations
HAIKOWER S.r.l.		433503760	manufacture(78619-100) , label(78619-100) , pack(78619-100)