Label: RAIN BREEZE TOOTHPASTE- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 51289-100-01, 51289-100-02, 51289-100-03, 51289-100-04, view more51289-100-05, 51289-100-06, 51289-100-07, 51289-100-08, 51289-100-09, 51289-100-10, 51289-100-11, 51289-100-12, 51289-100-13 - Packager: Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 26, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warning
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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
- Keep out of reach of children under 6 years of age
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RAIN BREEZE TOOTHPASTE
sodium fluoride pasteProduct 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