DR.PIK ORAL CARE GARGLE- sodium fluoride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Dr.pik Co.,ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Anticaries Uses: Helps prevent dental caries and remove bad breath.

Authorization status:

OTC monograph final

Summary of Product characteristics

DR.PIK ORAL CARE GARGLE- SODIUM FLUORIDE LIQUID
DR.PIK 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._
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ACTIVE INGREDIENT
Active ingredients: Sodium fluoride 0.05%
INACTIVE INGREDIENT
Inactive ingredients:
Water, Alcohol, Xyitol, Flavor (apple spearmint), L-Menthol, Acetic
acid, Sodium benzoate, Sodium
citrate, Citric acid, Stevioside, Sodium saccharin
PURPOSE
Purpose: Anticaries
WARNINGS
Warnings:
1) Keep the prescribed usage, capacity. 2) When using to children,
please use under the guidance and
supervision of the guardian. 3) Since this product is high in
concentration, be sure to add it to the water
supply tank of the Dr.pik’s 'Vacuum Oral Care'. 4) Use only for oral
cleaning. Do not use besides the
intended use. If large quantities have been swallowed, consult a
physician immediately. 5) Children
under 6 years old, please do not use without instructions from a
pharmacist or doctor. 6) Please keep
out of reach of children. 7) Avoid direct sunlight, keep as cool as
possible. 8) Please do not put in
another container for quality preservation.
KEEP OUT OF REACH OF CHILDREN
Please keep out of reach of children.
US ES
Uses:
Helps prevent dental caries and remove bad breath.
DIRECTIONS
Directions:
Add 15ml of Dr.pik Oral Care Gargle measured by the cap to the supply
tank of Vacuum Oral Care.
After filling water up to the line of the supply tank, add Dr.pik Oral
Care Gargle.
Do not use the solution without diluting for gargling purpose.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DR.PIK ORAL CARE GARGLE
sodium fluoride liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:728 57-0 10
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40
8 O)
FLUORIDE ION
0 .15 g in 30 0 mL
INACTIVE INGREDIENTS
INGRE