RxNorm Names
Review RxNorm Normal Forms
MASTIC DENT OULO ACTION
(sodium fluoride)
paste, dentifrice
[Chia Gi LTD]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc0a1a66-84a0-4b7e-9fa6-cc82d39c9abd| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE: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.
Active Ingredients
Drug Facts:
Active Ingredients:
- Sodium Fluoride 0.22% (0.12% w/v fluoride ion) - Anticavity
Warnings
Warnings:
- When using this product, if irritation occurs discontinue use.
- Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a poison control Center right away.
Directions
Directions:
- Adults and children 2 years and older.
- Brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
- Instruct in good brushing and rinsing habits (to minimize swallowing).
- Children under 2 years do not use unless directed by a dentist or a physician.
Inactive Ingredients
Inactive Ingredients:
Water, Sorbitol, Hydrated Silica, Glycerine, Peg-8, Fragrance, Sodium Lauryl Sarcosinate, Xanthan Gum, Titanium Dioxide, Chamomilla Recutita, Camelia Sinensis, Menthol Crystals, Sodium Saccharin, Allantoin, Pistacia Lentiscus (Mastic) Gum, Bisabolol, Glycyrrhetinic Acid, Sodium Hydroxide
| MASTIC DENT OULO ACTION
sodium fluoride paste, dentifrice |
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| Labeler - Chia Gi LTD (363215270) |
| Registrant - Chia Gi LTD (363215270) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Chia Gi LTD | 363215270 | manufacture(15304-4681), label(15304-4681), pack(15304-4681) | |
Revised: 12/2012
Document Id: ca4990dc-9be6-44e4-9a67-fb0eb0682b2f
Set id: fc0a1a66-84a0-4b7e-9fa6-cc82d39c9abd
Version: 1
Effective Time: 20121226
Chia Gi LTD
