BLINGDAY BUBBLE CANDY SOLID MOUTHWASH- sodium fluoride pellet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Dong Sung Bio Pharm. Co., Ltd.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Aids in the prevention of dental cavities. Helps to refresh your breath.
Authorization status:
OTC monograph final
Authorization number:
42361-081-01

BLINGDAY BUBBLE CANDY SOLID MOUTHWASH- sodium fluoride pellet

Dong Sung Bio Pharm. 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.

----------

42361-081-01 Drug Facts

Drug Facts

Sodium Fluoride 0.13% (0.06% w/w fluoride ion)

Drug Facts

Anticavity

Uses

Aids in the prevention of dental cavities. Helps to refresh your breath.

Warnings

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs.

Warnings

Keep this out of reach of children under 6 years of age. If more than used for rinsing is accidentally

swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older: Place 1 tablet into the mouth and start chewing. Swish the

bubbles between your teeth for 30 seconds to 1 minute and then spit out. Rinse out the residue with

water. Recommended daily usage: 1 tablet per each use, 2 to 5 uses per day. Children under 6 years of

age: consult a dentist or doctor before use.

Inactive Ingredients

Sorbitol, Sodium Bicarbonate, Microcrystalline Cellulose, Lactose, Anhydrous Citric Acid, Xylitol,

Sodium Lauryl Sulfate, Peppermint, Magnesium Stearate, L-Menthol, Erythritol, Sucralose, Acesulfame

Potassium, Sodium Chloride

Other Information

This product is not intended to replace brushing or flossing. Store in a cool, dry place.

Call (562) 802-0131 / www.dseshopusa.com

Bling:Day Bubble Candy Mouthwash - Mint Flavor

BLINGDAY BUBBLE CANDY SOLID MOUTHWASH

sodium fluoride pellet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4236 1-0 8 1

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 .0 0 0 6 6 mg in 1.1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITO L (UNII: 50 6 T6 0 A25R)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

PEPPERMINT (UNII: V9 5R5KMY2B)

MENTHO L (UNII: L7T10 EIP3A)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

ERYTHRITO L (UNII: RA9 6 B9 54X6 )

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:4236 1-0 8 1-

16 in 1 CASE

0 9 /0 9 /20 19

1

8 50 mg in 1 DOSE PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 9 /0 9 /20 19

Labeler -

Dong Sung Bio Pharm. Co., Ltd. (687811661)

Registrant -

Dong Sung World Wide USA, Inc. (784969219)

Dong Sung Bio Pharm. Co., Ltd.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Do ng Sung Bio Pharm. Co ., Ltd.

6 8 78 116 6 1

la be l(4236 1-0 8 1)

Revised: 9/2019

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