EUTHYMOL WHITENING SET- sodium fluoride kit

EUTHYMOL WHITENING SET by

Drug Labeling and Warnings

EUTHYMOL WHITENING SET by is a Otc medication manufactured, distributed, or labeled by LG HOUSEHOLD & HEALTH CARE LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

WARNINGS

Keep out of reach of children

Keep out of reach of children under 6 years of age.

Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Directions

• adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directly by a dentist.
• do not swallow.
• to minimize swallowing use a pea-sized amount in children under 6.
• supervise children's brushing until good habits are established.
• children under 2 years: ask a dentist

Inactive ingredients

Glycerin, Hydrated Silica, Sodium Hexametaphosphate, Water, Flavor/Aroma, PEG-6, Zinc Stearate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Tripotassium Phosphate, Carrageenan, Titanium Dioxide, Potassium Phosphate, Poloxamer 407, Sodium Saccharin, Algin, Tocopheryl Acetate, Xanthan Gum, Sucralose, D&C Red 33(CI 17200), FD&C Yellow 6(CI 15985), Eucalyptus Globulus Leaf Extract, Thymol

Questions?

1-866-993-4709

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EUTHYMOL WHITENING SET 
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-568

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-568-00	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	06/09/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 TUBE	424 g  in 4
Part 2	1 TUBE	70 g

Part 1 of 2

EUTHYMOL WHITENING 
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC: 53208-566
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALGIN (UNII: C269C4G2ZQ)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
RED 33 (UNII: 9DBA0SBB0L)
YELLOW 6 (UNII: H77VEI93A8)
POTASSIUM PHOSPHATE (UNII: B7862WZ632)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
THYMOL (UNII: 3J50XA376E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ZINC STEARATE (UNII: H92E6QA4FV)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU)
SODIUM HEXAMETAPHOSPHATE (UNII: P1BM4ZH95L)
PEG-6 (UNII: 5655G9Y8AQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-566-65	4 in 1 CARTON
1	NDC: 53208-566-63	106 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/09/2025

Part 2 of 2

EUTHYMOL WHITENING 
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC: 53208-566
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALGIN (UNII: C269C4G2ZQ)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
RED 33 (UNII: 9DBA0SBB0L)
YELLOW 6 (UNII: H77VEI93A8)
POTASSIUM PHOSPHATE (UNII: B7862WZ632)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
THYMOL (UNII: 3J50XA376E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
ZINC STEARATE (UNII: H92E6QA4FV)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU)
SODIUM HEXAMETAPHOSPHATE (UNII: P1BM4ZH95L)
PEG-6 (UNII: 5655G9Y8AQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-566-75	1 in 1 CARTON
1	NDC: 53208-566-73	70 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/09/2025

Labeler - LG HOUSEHOLD & HEALTH CARE LTD. (688276187)