Label: 100 TOOTHPAST E NIGHT- sodium monofluorophosphate gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 81307-030-01, 81307-030-02 - Packager: MGRU
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
D-Sorbitol Solution, Aqua, Silicon Dioxide, Chamomile Extract, Rhatany Essence, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, Peppermint Oil, Aqua Mint Flavor, Grapefruit Seed Extract, L-Menthol, Aluminium Chlorohydroxy Allantoinate, Xylitol, Enzymatically Modified Stevia, Green Tea Extract, Aloe Extract, Eucalyptus Extract, Sage Extract
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Directions
■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or three times a day, or as directed by a dentist or physician
■ Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
■ Children under 2 years: Consult a dentist - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
100 TOOTHPAST E NIGHT
sodium monofluorophosphate gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81307-030 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.75 g in 100 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81307-030-02 1 in 1 CARTON 12/01/2020 1 NDC:81307-030-01 100 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 final part355 12/01/2020 Labeler - MGRU (695672240) Registrant - MGRU (695672240) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(81307-030)
