YOUDUO GENTLE WHITENING FLUORIDE- sodium monofluorophosphate paste, dentifrice
Yangzhou Holyshine Industrial 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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Youduo Gentle Whitening Fluoride Toothpaste

Active ingredient

Sodium monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

aids in the prevention of cavities

Warnings

Keep out of reach of children under 6 yrs of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

do not swallow

to minimize swallowing, use a pea-sized amount in children under 6 years old

supervise children's brushing until good habits are established

children under 2yrs.: ask a dentist before use.

Inactive ingredients

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

Manufacturer : Yangzhou Holyshine Industrial Co., Ltd.
Add: No 15 taoyuan raod , Guangling Industrail Park,
Yangzhou city .Jiangsuprovice ,China

NEW Youduo
Gentle Whitening Fluoride Toothpaste
120g

Youduo Gentle Whitening Fluoride Toothpaste

YOUDUO GENTLE WHITENING FLUORIDE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60931-001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60931-001-12	1 in 1 BOX	10/31/2013	03/15/2016
1		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/31/2013	03/15/2016

Labeler - Yangzhou Holyshine Industrial Co., Ltd. (421141948)

Revised: 8/2017

Document Id: 55edd4bd-e918-356c-e054-00144ff8d46c

Set id: 16af62ac-9aef-420c-97b1-957dd60c65df

Version: 4

Effective Time: 20170804

Yangzhou Holyshine Industrial Co., Ltd.