Label: DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 70905-0017-1 - Packager: Dr. Althea
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 22, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
How to use:
1) Squeeze toothpaste on to toothbrush.
2) Brush thoroughly at least twice a day.
3) Brush for 3+ minutes.
4) Rinse out thoroughly with water.Directions
■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
■ Supervise children as necessary until capable of using without supervision.
■ Children under 2 years of age: Consult a dentist or doctor.
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WARNINGS
Cautions:
1) If following symptoms occur after product use, stop using immediately: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70905-0017 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70905-0017-1 120 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/01/2018 Labeler - Dr. Althea (689694436) Registrant - Dr. Althea (689694436) Establishment Name Address ID/FEI Business Operations Kumho Dental Pharm Co Ltd 631133766 manufacture(70905-0017) Establishment Name Address ID/FEI Business Operations Dr. Althea 689694436 label(70905-0017)
