Label: AQUAPICK WHITENING BUBBLEPICK- sodium fluoride liquid
- 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.
Updated May 2, 2013
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- Children under the age of 6 should be accompanied by an adult when using this product and should use no more than a pea-sized amount. If over consumption occurs, please contact a qualified medical professional immediately.
- Avoid sucking or swallowing.
- For oral hygiene purposes only.
- If any side effects occur, please contact a qualified medical or dental professional immediately.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
AQUAPICK WHITENING BUBBLEPICK
sodium fluoride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58399-1001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.001 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) XYLITOL (UNII: VCQ006KQ1E) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SAGE (UNII: 065C5D077J) CHAMOMILE (UNII: FGL3685T2X) GRAPEFRUIT (UNII: O82C39RR8C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58399-1001-1 50 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/02/2013 Labeler - Aquapick Co., Ltd (688444236) Registrant - Aquapick Co., Ltd (688444236) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co. Ltd 687846360 manufacture(58399-1001)