HYGIENIGEL- hand sanitizer gel 
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 Gel - 70%

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

Label

HYGIENIGEL 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78619-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78619-200-075000 mL in 1 CAN; Type 0: Not a Combination Product02/25/2021
2NDC:78619-200-061000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2021
3NDC:78619-200-05500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2021
4NDC:78619-200-04100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2021
5NDC:78619-200-0370 mL in 1 POUCH; Type 0: Not a Combination Product02/25/2021
6NDC:78619-200-0230 mL in 1 POUCH; Type 0: Not a Combination Product02/25/2021
7NDC:78619-200-082 mL in 1 POUCH; Type 0: Not a Combination Product02/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/25/2021
Labeler - HAIKOWER S.r.l. (433503760)
Registrant - MELCHIONNA PLLC (039407173)
Establishment
NameAddressID/FEIBusiness Operations
HAIKOWER S.r.l.433503760manufacture(78619-200) , label(78619-200) , pack(78619-200)

Revised: 3/2021
Document Id: bc911eb3-52d8-c42d-e053-2995a90a02b4
Set id: bc32a828-3fd4-4494-e053-2a95a90a596a
Version: 3
Effective Time: 20210302
 
HAIKOWER S.r.l.