Hygienium by Grande Gloria Production S.A. Antibacterial soap

Hygienium by

Drug Labeling and Warnings

Hygienium by is a Otc medication manufactured, distributed, or labeled by Grande Gloria Production S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYGIENIUM- antibacterial soap liquid 
Grande Gloria Production S.A.

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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Antibacterial soap

dosage form - liquid

Route of administration- topical

Warnings

For external use only, Flammable. Keep away from heat or flame.

Use: Product used as antibacterial liquid soap for human hygiene. Skincare and protection

When using this product keep out of eyes, ears, and mouth. In case of constant with eyes, rinse eyes thoroughly with water.

Direction for use: Place enough products on your hands to cover all surfaces. Rub hands together until dry. Apply water.

Inactive ingredients: water, Cocamidopropyl betaine, PEG-200 Glyceryl, PEG-7 Glyceryl, Lauryl glucoside, Gossypium extract, Parfum

Do not use in children less than 2 months of age. Keep out of children's reach, except under adult supervision. If swallowed get medical help or contact a poison control center right away.

Use for human hygiene. Antibacterial hand soap

Benzalkonium chloride 1% v/v- antiseptic

Chlorhexidine Digluconate 0.4%v/v- antiseptic

300ml

Do not use in children less than 2 months of age and on open wounds. Please enough product on hands to cover all surface. Supervise children under 6 years of age when using this product.

Antibacterial liquid soap

1% benzalkonium chloride

HYGIENIUM 
antibacterial soap liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81592-1679
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	10 mg  in 1 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-BETAINE (UNII: 03DH2IZ3FY)
PEG-200 HYDROGENATED GLYCERYL PALMATE (UNII: W161T051Y1)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81592-1679-4	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 81592-1679-2	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	12/31/2021

Labeler - Grande Gloria Production S.A. (534041167)

Registrant - Grande Gloria Production S.A. (534041167)

Establishment
Name	Address	ID/FEI	Business Operations
Grande Gloria Production S.A.		534041167	manufacture(81592-1679)

Revised: 12/2021

Document Id: d474c6d3-4203-96d1-e053-2995a90a24d9

34390-5

Set id: bedc2209-ee2e-746a-e053-2995a90a147d

Version: 3

Effective Time: 20211231