HYGIENIGEL- hand sanitizer gel

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

Carbomer, Dmdm Hydantoin, Ethylhexylglycerin, Fragrance, Melaleuca Alternifolia Leaf Oil, Panthenol, Peg/ppg-14/4 Dimethicone, Peg-60 Lanolin, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

Active Ingredient

Ethyl Alcohol 70% v/v

OTC - Ask Doctor

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 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

OTC - Stop use

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

Warnings

Flammable.

Keep away from flame and fire.

For external use only.

Indication and USage

Hand Sanitizer to help reduce bacteria on the skin

Label

INGREDIENTS AND APPEARANCE

HYGIENIGEL 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78619-200
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
LANOLIN (UNII: 7EV65EAW6H)
TRIETHANOLAMINE LAURATE (UNII: 9403LC9W1J)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER 1342 (UNII: 809Y72KV36)
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)
PANTHENOL (UNII: WV9CM0O67Z)
PEG/PPG-14/4 DIMETHICONE (UNII: 646XNV22YX)
PROPYLENE GLYCOL 1-LAURATE (UNII: M4AW13H75T)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78619-200-07	5000 mL in 1 CAN; Type 0: Not a Combination Product	02/25/2021
2	NDC: 78619-200-06	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2021
3	NDC: 78619-200-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2021
4	NDC: 78619-200-04	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2021
5	NDC: 78619-200-03	70 mL in 1 POUCH; Type 0: Not a Combination Product	02/25/2021
6	NDC: 78619-200-02	30 mL in 1 POUCH; Type 0: Not a Combination Product	02/25/2021
7	NDC: 78619-200-08	2 mL in 1 POUCH; Type 0: Not a Combination Product	02/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/25/2021

Labeler - HAIKOWER S.r.l. (433503760)

Registrant - MELCHIONNA PLLC (039407173)

Establishment
Name	Address	ID/FEI	Business Operations
HAIKOWER S.r.l.		433503760	manufacture(78619-200) , label(78619-200) , pack(78619-200)