Rain Breeze Toothpaste (Sodium Fluoride) Paste [Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.] -

RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]
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NDC	51289-100-01, 51289-100-02, 51289-100-03, 51289-100-04, 51289-100-05, 51289-100-06, 51289-100-07, 51289-100-08, 51289-100-09, 51289-100-10, 51289-100-11, 51289-100-12, 51289-100-13
Set ID	6265ffa0-2756-41f5-bce8-c1fd81676bae
Category	HUMAN OTC DRUG LABEL
Packager	Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART355

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Active Ingredient

Sodium Fluoride 0.22%(0.1%w/v fluoride ion)
Purpose

Anticavity
Use

helps protect against cavities
Warning

Keep out of reach of children under 6 years of age.
If more than used for brushing is accidently swallowed get medical help or contact a poison control center immediately.
Directions

Adults and children 6 years of age and older:brush teeth thoroughly, preferably after each meal or at least twice a day,
or as directed by a dentist or a physician.
Children 2 to 6:Use only a pea sized amount and supervise child’s brushing and rinsing to minimize swallowing.
Children under 2:Ask dentist or physician
Inactive Ingredients

Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavour, Treated Water, SCMC,
Sodium Lauryl Sulfate
Keep out of reach of children under 6 years of age

Keep out of reach of children under 6 years of age
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAIN BREEZE TOOTHPASTE
sodium fluoride paste

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.22 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Sorbitol (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
Sodium Lauryl Sulfate (UNII: 368GB5141J)

#	Item Code	Package Description
Packaging
1	NDC:51289-100-01	17 g in 1 TUBE
2	NDC:51289-100-02	24 g in 1 TUBE
3	NDC:51289-100-03	35 g in 1 TUBE
4	NDC:51289-100-04	43 g in 1 TUBE
5	NDC:51289-100-05	50 g in 1 TUBE
6	NDC:51289-100-06	70 g in 1 TUBE
7	NDC:51289-100-07	78 g in 1 TUBE
8	NDC:51289-100-08	90 g in 1 TUBE
9	NDC:51289-100-09	100 g in 1 TUBE
10	NDC:51289-100-10	120 g in 1 TUBE
11	NDC:51289-100-11	130 g in 1 TUBE
12	NDC:51289-100-12	150 g in 1 TUBE
13	NDC:51289-100-13	180 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/21/2010

Labeler - Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. (527127383)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.		527127383	manufacture

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