Multi effect mouthwash by NICEDAE GROUP LLC 85824-002

Multi effect mouthwash by

Drug Labeling and Warnings

Multi effect mouthwash by is a Otc medication manufactured, distributed, or labeled by NICEDAE GROUP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MULTI EFFECT MOUTHWASH- multi effect mouthwash mouthwash 
NICEDAE GROUP LLC

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85824-002

Active Ingredient(s)

Sodium Fluoride 0.05%

Cetylpyridinium Chloride 0.02%

Purpose

Anticavity
Antiseptic

Use

Use: Aids in the prevention of dental cavities and reduces oral bacteria.

Warnings

●Do not use ifyou are allergic to any ingredient in this product or in children under 12 without dental advice.
●When using this product, do not swallow, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
●Stop use and ask a doctor if irnitation, swelling, or rash develops.
●Keep out of reach of children. If swallowed, immediately seek medical help or contact a Poison Control Center right away.

Do not use

Do not use ifyou are allergic to any ingredient in this product or in children under 12 without dental advice.

When using this product, do not swallow, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if iritation, swelling, or rash develops.

Keep out of reach of children. If swallowed, immediately seek medical help or contact a Poison Control Center right away.

Directions

Open the packet along the dotted line, rinse your mouth for 30 seconds and spitit out. Do not swallow.

Other information

This product contains plant extracts. If there is a small amount of precipitation. It is a normal phenomenon and can be used with confidence.

Inactive ingredients

WATER, SORBITOL ERYTHRITOL, PROPYLENE GLYCOL, XYLUTOL, POTASSIUM SORBATE, POLYSORBATE 20, SODIUM BENZOATE, AROMA DIPOTASSIUM GLYCYRRHIZATE, CITRIC ACID, DISODIUM EDTA, PANAX GINSENG EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, CURCUMALONGA (TURMERIC) ROOT EXTRACT,ANGELICAPOLYMORPHA SINENSIS ROOT EXTRACT, REHMANNIA GLUTINOSAROOT EXTRACT, SODIUMCITRATE

Package Label - Principal Display Panel

MULTI EFFECT MOUTHWASH 
multi effect mouthwash mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85824-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.02 U  in 100 U
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.05 U  in 100 U

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ERYTHRITOL (UNII: RA96B954X6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID (UNII: 2968PHW8QP)
PANAX GINSENG ROOT (UNII: CUQ3A77YXI)
CURCUMA LONGA (TURMERIC) ROOT (UNII: 856YO1Z64F)
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85824-002-01	30 U in 1 BOX; Type 0: Not a Combination Product	06/26/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/26/2025	12/31/2025

Labeler - NICEDAE GROUP LLC (119275091)

Establishment
Name	Address	ID/FEI	Business Operations
NICEDAE GROUP LLC		119275091	manufacture(85824-002)

Revised: 1/2026

Document Id: 48c91d95-50b0-7f26-e063-6394a90af4b9

34390-5

Set id: 38754b69-3c75-b139-e063-6394a90a8bb9

Version: 2

Effective Time: 20260119