Multi effect mouthwash by NICEDAE GROUP LLC 85824-003

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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85824-003

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 toany ingredient in this product or inchildren under 12 without dentaladvice.
●When using this product, do not swallow, avoid contact witheyes. Ifcontact occurs, rinse thoroughly with water.
●Stop use and ask a doctor firritation, swelling, or rash develops.
● Keep out of reach of children. Ifswallowed, immediatelyseek medical help or contact aPoisonControl Center right away.

Do not use

●Do not use ifyou are alergic toany ingredient in this product or inchildren under 12 without dentaladvice.

●When using this product, do not swallow, avoid contact witheyes. Ifcontact occurs, rinse thoroughly with water.

●Stop use and ask a doctor ifirritation, swelling,or rash develops.

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

Directions

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

Other information

This product contains plant extracts. Ifthere is a small amount of precipitation, it is a normal
phenomenon and can be used with confidence.

Inactive ingredients

WATER, SORBITOL, ERYTHRITOL PROPYLENE GLYCOL, XYLITOL, POTASSIUM SORBATE, POLYSORBATE 20,
SODIUM BENZOATE, AROMA, DIPOTASSIUM GLYCYRRHIZATE, CITRIC ACID, DISODIUM EDTA PANAX GINSENG
EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, PHEU ODENDRON 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: 85824-003
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 g  in 100 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PANAX GINSENG ROOT (UNII: CUQ3A77YXI)
PINEAPPLE (UNII: 2A88ZO081O)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)
CURCUMA LONGA (TURMERIC) ROOT (UNII: 856YO1Z64F)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85824-003-01	380 mL in 1 BOTTLE; 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(85824-003)

Revised: 1/2026

Document Id: 48c9209f-d442-8d20-e063-6294a90ad652

34390-5

Set id: 387650d6-cec6-3dbb-e063-6294a90a6b65

Version: 2

Effective Time: 20260119