SMILEACTIVES PRO WHITENING- fluoride paste, dentifrice 
Oraceutical

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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SmileActives ProWhitening Toothpaste

Active ingredients / Purpose

Sodium Fluoride (0.15% Fluoride Ion) ............Anticavity

Uses

  • aids in the prevention of dental cavities

When using this product, if irritation occurs discontinue use.

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. Children under 2 years of age, consult a dentist or doctor

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 6 years of age: consult a dentist or a doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, flavor, cellulose gum, sodium lauryl sulfate, sodium methyl cocoyl taurate, sodium benzoate, sodium saccharin, sodium hydroxide

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Carton label

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Tube Label

SMILEACTIVES  PRO WHITENING
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67303-501
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
PYRROLIDONE (UNII: KKL5D39EOL)  
POVIDONE K25 (UNII: K0KQV10C35)  
Product Characteristics
Colorwhite (White) Score    
ShapeSize
FlavorMINT (Vanilla Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67303-501-191 in 1 CARTON01/28/201403/01/2016
1NDC:67303-501-12157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/28/201403/01/2016
Labeler - Oraceutical (005693770)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(67303-501) , pack(67303-501)

Revised: 2/2019
 
Oraceutical