[De-listing] SALARIUM PREMIUM SALT TOOTHPASTE GIFT SET

SALARIUM PREMIUM SaltTOOTHPASTE GIFT SET by

Drug Labeling and Warnings

SALARIUM PREMIUM SaltTOOTHPASTE GIFT SET by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALARIUM PREMIUM SALTTOOTHPASTE GIFT SET- sodium fluoride 
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 PREMIUM SALT TOOTHPASTE GIFT SET

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

SALARIUM GUERANDE SALT PREMIUMTOOTHPASTE

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), Solar Salt, Edetate Disodium, Titanium Dioxide

SALARIUM MALDON SALT PREMIUMTOOTHPASTE

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

SALARIUM ANDES SALT PREMIUMTOOTHPASTE

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), Mineral Salts, Edetate Disodium, Titanium Dioxide

SALARIUM PREMIUM SALT TOOTHPASTE GIFT SET

SALARIUM PREMIUM SALTTOOTHPASTE GIFT SET 
sodium fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67225-1104
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-1104-31 in 1 BOX04/22/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 110 g
Part 21 TUBE 110 g
Part 31 TUBE 110 g
Part 1 of 3
SALARIUM GUERANDE SALT PREMIUMTOOTHPASTE 
sodium fluoride paste, dentifrice
Product Information
Item Code (Source)NDC: 67225-1103
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
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SEA SALT (UNII: 87GE52P74G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-1103-21 in 1 BOX
1NDC: 67225-1103-1110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/22/2021
Part 2 of 3
SALARIUM MALDON SALT PREMIUMTOOTHPASTE 
sodium fluoride paste, dentifrice
Product Information
Item 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
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SEA SALT (UNII: 87GE52P74G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-1102-21 in 1 BOX
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 finalpart35504/22/2021
Part 3 of 3
SALARIUM ANDES SALT PREMIUMTOOTHPASTE 
sodium fluoride paste, dentifrice
Product Information
Item Code (Source)NDC: 67225-1101
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
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-1101-21 in 1 BOX
1NDC: 67225-1101-1110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/22/202105/12/2022
Labeler - Aekyung Industrial Co., Ltd. (690511126)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Industrial Co., Ltd.690511126manufacture(67225-1101, 67225-1102, 67225-1103, 67225-1104)

Revised: 5/2022