[De-listing] SALARIUM MALDON SALT PREMIUM TOOTHPASTE 67225-1102-2

SALARIUM MALDON SALT PremiumToothpaste by

Drug Labeling and Warnings

SALARIUM MALDON SALT PremiumToothpaste by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALARIUM MALDON SALT PREMIUMTOOTHPASTE- sodium fluoride paste, dentifrice 
Aekyung Industrial Co., Ltd.

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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[De-listing] SALARIUM MALDON SALT PREMIUM TOOTHPASTE
67225-1102-2

Active ingredient

Sodium fluoride 0.22%

Use

Aids in the prevention of dental decay.

Warnings

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

■ Adults and children 2 years of age a nd older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. ■ Children under 6 years: Instruct in good brushing and rinsing habits (to minimize swallowing). Use only a pea-sized amount. ■ Children under 2 years of age: Consult a dentist or doctor. ■ Supervise children as necessary until capable of using without supervision.

Purpose

Anticavity

Inactive ingredients

Liquid Sorbitol, Dental-Type Silica, Water, Sodium Lauryl Sulfate, Flavor, Sodium Chloride, PEG 1500, Carboxymethyl Cellulose Sodium, Saccharin Sodium Hydrate, Xanthan Gum, Pyridoxin Hydrochloride (Vitamin B6), Reworked Salt, Edetate Disodium, Titanium Dioxide

67225-1102-2

SALARIUM MALDON SALT PREMIUMTOOTHPASTE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67225-1102
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.242 g  in 110 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-1102-21 in 1 BOX04/21/2021
1NDC: 67225-1102-1110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/21/202105/11/2022
Labeler - Aekyung Industrial Co., Ltd. (690511126)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Industrial Co., Ltd.690511126manufacture(67225-1102)

Revised: 5/2022