NDC | 37000-167-05 |
Set ID | 7baa77f5-fe45-6566-e053-2991aa0a381f |
Category | HUMAN OTC DRUG LABEL |
Packager | The Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
-
Directions
- Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste.
- Vigorously swish the 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 until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
KIDS CREST BUBBLEGUM RUSH
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-167 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) PHOSPHORIC ACID (UNII: E4GA8884NN) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN (UNII: FST467XS7D) Product Characteristics Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-167-05 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/03/2018 Labeler - The Procter & Gamble Manufacturing Company (004238200)