RAIN BREEZE TOOTHPASTE- sodium fluoride paste

Rain Breeze Toothpaste by

Drug Labeling and Warnings

Rain Breeze Toothpaste by is a Otc medication manufactured, distributed, or labeled by Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51289-100
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/21/2010

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

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