Multi effect mouthwash by NICEDAE GROUP LLC 85824-001

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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85824-001

Active Ingredient(s)

Sodium Fluoride 0.05%

Cetylpyridinium Chloride 0.02%

Purpose

Anticavity
Antiseptic

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 dentaladvice
●When using this product, do not swallow, avoid contact witheyes. If contact occurs, rinse thoroughlywith water.
●Stop use and ask a doctor firritation, swelling,or rashdevelops.
●Keep out of reach of children. If swallowed, immediatelyseek medical help or contact a PoisonControl Center right away.

Do not use

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

When using this product, do not swallow, avoid contact witheyes. If contact occurs, rinse thoroughlywith water.

Stop use and ask a doctor firritation, swelling,or rashdevelops.

Keep out of reach of children. If swallowed, immediatelyseek medical help or contact a PoisonControl Center right away.

Directions

Directions : Swish for a full 30 seconds and spit it out, never drink or swallow mouthwash.

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, PROPYL .ENE GLYCOL, XM ITOL, POTASSIUM SORBATE, POLYSORBATE 20,
SODIUM BENZOATE, AROMA, DIPOTASSIUM GLYCYRRHIZATE CITRIC ACID, DISODIUM EDTA PANAX GINSENG
EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, CURCUMA
LONGA (TURMERIC) ROOT EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, REHMANNIA
GLUTINOSA ROOT EXTRACT, SODIUM CITRATE

Package Label - Principal Display Panel

MULTI EFFECT MOUTHWASH 
multi effect mouthwash mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85824-001
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
CURCUMA LONGA (TURMERIC) ROOT (UNII: 856YO1Z64F)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
PANAX GINSENG ROOT (UNII: CUQ3A77YXI)
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
CITRIC ACID (UNII: 2968PHW8QP)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85824-001-01	380 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/25/2025	12/31/2025

Labeler - NICEDAE GROUP LLC (119275091)

Establishment
Name	Address	ID/FEI	Business Operations
NICEDAE GROUP LLC		119275091	manufacture(85824-001)

Revised: 1/2026

Document Id: 48c92305-60a3-1a95-e063-6394a90a13cd

34390-5

Set id: 3860be04-7e36-2eae-e063-6394a90a765e

Version: 2

Effective Time: 20260119