DR.ALTHEA IAMNATURALTOOTHPASTE FOR ADULTS- sodium monofluorophosphate paste, dentifrice 
Dr. Althea

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.

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SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

Aids in the prevention of dental cavities.

Keep out of reach of children

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.

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.

SILVER, HYDRATED SILICA, CELLULOSE GUM, SORBITIOL, GLYCERIN, PEG-32, XYLITOL, MENTHOL, WATER, ETC.

For dental use only

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DR.ALTHEA IAMNATURALTOOTHPASTE FOR ADULTS 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0020
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70905-0020-1120 g in 1 TUBE; Type 0: Not a Combination Product03/01/201803/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/01/201803/15/2018
Labeler - Dr. Althea (689694436)
Registrant - Dr. Althea (689694436)
Establishment
NameAddressID/FEIBusiness Operations
Kumho Dental Pharm Co Ltd631133766manufacture(70905-0020)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Althea689694436label(70905-0020)

Revised: 3/2018
 
Dr. Althea