AQUAPICK WHITENING BUBBLEPICK- sodium fluoride liquid

Aquapick Whitening Bubblepick by

Drug Labeling and Warnings

Aquapick Whitening Bubblepick by is a Otc medication manufactured, distributed, or labeled by Aquapick Co., Ltd, Kolmar Korea Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

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

PURPOSE

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 CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

brush with toothbrush and rinse thoroughly

WARNINGS

- 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

for dental use only

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)