Rain Breeze Toothpaste

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.22g in 100g
Labeler: Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
NDC Code: 51289-100

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.

TOOTHPASTE DRUG FACTS

Active IngredientSodium Fluoride 0.22%(0.1%w/v fluoride ion)

PurposeAnticavity

Usehelps protect against cavities

WarningKeep 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.

DirectionsAdults 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 IngredientsSorbitol, 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 ageKeep out of reach of children under 6 years of age

RAIN BREEZE TOOTHPASTE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51289-100
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (Fluoride Ion) SODIUM FLUORIDE0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
SILICON DIOXIDE 
METHYLPARABEN 
PROPYLPARABEN SODIUM 
SACCHARIN SODIUM 
WATER 
CARBOXYMETHYLCELLULOSE SODIUM 
Sodium Lauryl Sulfate 
Packaging
#Item CodePackage Description
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/FEIOperations
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.527127383manufacture

Revised: 08/2010
 
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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