NDC | 55504-0540-1, 55504-0540-2, 55504-0540-3 |
Set ID | 85a0fde5-4d1c-450f-9e65-2849b43a72e2 |
Category | HUMAN OTC DRUG LABEL |
Packager | Donovan Industries, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
-
INACTIVE INGREDIENT
Directions : Adults and children 2 yrs. and older. Brush teeth thoroughly after
meals or at least twice a day or use as directed by a dentist or physician.
Children under 6 yrs.: To minimize swallowing use a pea sized amount and
supervise brushing until good habits are established.
Children Under 2 years: Ask a dentist or physician.
- DESCRIPTION
- DESCRIPTION
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAWNMIST
toothbrush, toothpaste and floss kit pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55504-0540 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.76 g in 3 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PEPPERMINT OIL (UNII: AV092KU4JH) SACCHARIN (UNII: FST467XS7D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55504-0540-1 2.83 g in 1 KIT 2 NDC:55504-0540-2 2.83 g in 1 KIT 3 NDC:55504-0540-3 3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/01/2009 Labeler - Donovan Industries, Inc. (096662267) Registrant - Fulijaya Manufacturing SDN. BHD. (652087115) Establishment Name Address ID/FEI Business Operations Fulijaya Manufacturing SDN. BHD. 652087115 manufacture Establishment Name Address ID/FEI Business Operations Donovan Industries, Inc. 096662267 import