NDC | 71167-002-01, 71167-002-02 |
Set ID | 4b50f74b-d1d4-2827-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | HUAIAN ZONGHENG BIO-TECH CO., LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- Active Ingredient
- Purpose
- Use
- Warning
-
Directions
Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's burshing ntil good habits are established
children under 2 years ask a dentist
- Inactive Ingredients
- Keep out of reach of children under 6 years of age
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WHITE-GLO 2IN1 WITH MOUTHWASH
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71167-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength CHONDRUS CRISPUS (UNII: OQS23HUA1X) CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) SODIUM SILICATE (UNII: IJF18F77L3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71167-002-01 24 in 1 BOX 07/10/2016 1 150 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71167-002-02 48 in 1 BOX 07/10/2016 2 150 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 07/10/2016 Labeler - HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733) Establishment Name Address ID/FEI Business Operations HUAIAN ZONGHENG BIO-TECH CO., LTD 527152733 manufacture(71167-002)