HYGIENIGEL HAND SANITIZER 500ML

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 500ml 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 HAND SANITIZER 500ML

HYGIENIGEL HAND SANITIZER 500ML - DOSAGE

HYGIENIGEL HAND SANITIZER - 500ML - WANRNINGS

HYGIENIGEL HAND SANITIZER - 500ML INACTIVE INGREDIENT

HYGIENIGEL HAND SANITIZER 500ML - INDICATION AND U

HYGIENIGEL HAND SANITIZER - 500ML - OTC KEEP OUT OF REACH OF CHILDREN

HYGIENIGEL HAND SANITIZER 500ML - OTC PURPOSE

HYGIENIGEL HAND SANITIZER - 500ML - OTC ACTIVE INGREDIENT

HYGIENIGEL HAND SANITIZER 500 ML - PACKAGE LABEL

HYGIENIGEL 
hand sanitizer 500ml gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78619-004
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)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78619-004-04	70 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	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(78619-004) , pack(78619-004) , label(78619-004)

Revised: 2/2021

Document Id: bc3022f5-34f2-85c6-e053-2995a90a4ae4

34390-5

Set id: a812990f-dc0e-72e3-e053-2995a90a7de7

Version: 2

Effective Time: 20210225