Label: ZOHAR ANTI CAVITY MOUTHWASH BUBBLE GUM FLAVOUR- sodium fluoride liquid
- NDC Code(s): 84045-002-00
- Packager: ZOHAR KOSHER LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 27, 2024
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- Drug Facts
- Active ingredient
- Use
- Warnings
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Directions
- Adults and children 6 years of age and older:
- use once a day after brushing your teeth with a toothpaste
- vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary untill capable of using without supervision.
- Children under 6 years of age: consult a dentist or doctor.
- Inactive ingredients
- Label
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INGREDIENTS AND APPEARANCE
ZOHAR ANTI CAVITY MOUTHWASH BUBBLE GUM FLAVOUR
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84045-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLOXAMER 407 (UNII: TUF2IVW3M2) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84045-002-00 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 03/15/2024 Labeler - ZOHAR KOSHER LIMITED (221033261)