![DR. ZENNI JUNIOR TOOTHPASTE(LIME FLAVOR) (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ZENITON CO.,LTD.]](https://medic.hrt.org//dailymed/images/85ff061e-4e95-2427-e053-2a91aa0ad433/label4.jpg)
| NDC | 73029-0004-1 |
| Set ID | 85ff061e-4e95-2427-e053-2a91aa0ad433 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Zeniton Co.,Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART355 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Storage method
1. Keep it at room temperature in a classified container.
2. Cover and store at room temperature.
3. Store in a not moisture and cool place.
4. Air may come out during use of this product, but there is no problem with its weight.
Usage Precautions
1. Be careful not to swallow. Rinse mouth thoroughly after use
2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.
3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.
4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.
5. Keep out of the reach of children under 6 years of age.
6. The fluorine content of this toothpaste is 1,000ppm.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR. ZENNI JUNIOR TOOTHPASTE(LIME FLAVOR)
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73029-0004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.379 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73029-0004-1 60 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/01/2019 Labeler - Zeniton Co.,Ltd. (688416831) Registrant - Zeniton Co.,Ltd. (688416831) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(73029-0004) Establishment Name Address ID/FEI Business Operations Zeniton Co.,Ltd. 688416831 label(73029-0004)
