HYGIENIGEL by HAIKOWER S.r.l. / MELCHIONNA PLLC Hygenigel 5Lt

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]

HYGIENIGEL- hand sanitizer gel 5l 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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Hygenigel 5Lt

Package and Label

HYGIENIGEL 
hand sanitizer gel 5l gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78619-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78619-010-10	70 mL in 1 TANK; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2021	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(78619-010) , label(78619-010) , pack(78619-010)

Revised: 2/2021

Document Id: bc3025d4-4124-5af9-e053-2995a90a76b7

34390-5

Set id: bb8bc3ff-113d-a08d-e053-2a95a90acac1

Version: 2

Effective Time: 20210225