HYGIENIGEL- hand sanitizer solution, gel forming / drops 
HAIKOWER S.r.l.

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.

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Hygienigel 75% Spray

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

PACKAGE LABEL

HYGIENIGEL 
hand sanitizer solution, gel forming / drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78619-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78619-100-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/26/2021
Labeler - HAIKOWER S.r.l. (433503760)
Registrant - MELCHIONNA PLLC (039407173)
Establishment
NameAddressID/FEIBusiness Operations
HAIKOWER S.r.l.433503760manufacture(78619-100) , label(78619-100) , pack(78619-100)

Revised: 2/2021
Document Id: bc43b659-d56b-3d4b-e053-2a95a90a1de5
Set id: bc43b659-d56a-3d4b-e053-2a95a90a1de5
Version: 1
Effective Time: 20210226
 
HAIKOWER S.r.l.