AQUAPICK WHITENING BUBBLEPICK  - sodium fluoride liquid 
Aquapick Co., Ltd

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 Facts

sodium fluoride


allantoin, xylitol, greentea extract, sage extract, chamomile extract, grapefruit seed extract


Clean and maintain the aesthetics and health of teeth including but not warranted to the prevention of gingival and periodontal disease

keep out of reach of the children


brush with toothbrush and rinse thoroughly



- 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.



for dental use only


package insert
AQUAPICK WHITENING BUBBLEPICK  
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58399-1001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.001 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
XYLITOL (UNII: VCQ006KQ1E)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SAGE (UNII: 065C5D077J)  
CHAMOMILE (UNII: FGL3685T2X)  
GRAPEFRUIT (UNII: O82C39RR8C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58399-1001-150 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/02/2013
Labeler - Aquapick Co., Ltd (688444236)
Registrant - Aquapick Co., Ltd (688444236)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co. Ltd687846360manufacture(58399-1001)

Revised: 5/2013
Document Id: 2fd4e561-efc9-4704-81a6-3f98069e7f45
Set id: ceec3fd2-f7b5-4e64-a4d8-b95123202b39
Version: 1
Effective Time: 20130502
 
Aquapick Co., Ltd