RAIN BREEZE TOOTHPASTE - sodium fluoride paste 
Yangzhou Hengyuan Daily Chemical Plastic 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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TOOTHPASTE DRUG FACTS

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

label
RAIN BREEZE TOOTHPASTE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51289-100
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51289-100-0117 g in 1 TUBE
2NDC:51289-100-0224 g in 1 TUBE
3NDC:51289-100-0335 g in 1 TUBE
4NDC:51289-100-0443 g in 1 TUBE
5NDC:51289-100-0550 g in 1 TUBE
6NDC:51289-100-0670 g in 1 TUBE
7NDC:51289-100-0778 g in 1 TUBE
8NDC:51289-100-0890 g in 1 TUBE
9NDC:51289-100-09100 g in 1 TUBE
10NDC:51289-100-10120 g in 1 TUBE
11NDC:51289-100-11130 g in 1 TUBE
12NDC:51289-100-12150 g in 1 TUBE
13NDC:51289-100-13180 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/21/2010
Labeler - Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. (527127383)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.527127383manufacture

Revised: 8/2010
Document Id: 728deb34-df4e-44f6-b9b7-4c4f4968ee40
Set id: 6265ffa0-2756-41f5-bce8-c1fd81676bae
Version: 3
Effective Time: 20100826
 
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.