Label: IPANA WINTERGREEN FLUORIDE- sodium monofluorophosphate paste
- NDC Code(s): 69510-010-19
- Packager: Maxill Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
- Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 2 years: Consult a dentist or doctor.
- Inactive Ingredients
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Product Label
ipana
Since 1901
Wintergreen
FLUORIDE
TOOTHPASTE
FIGHTS CAVITIES
NET WT. 0.66 OZ (19g)
ITEM 40515
Dist. by:
Maxill inc.
Cortland, OH, USA 44410
1-800-268-8633 www.maxill.com
Made in Malaysia
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INGREDIENTS AND APPEARANCE
IPANA WINTERGREEN FLUORIDE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69510-010 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69510-010-19 1 in 1 BOX 01/05/2015 1 19 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/31/2014 Labeler - Maxill Inc. (079343581) Establishment Name Address ID/FEI Business Operations AmLion Toothpaste Sdn. Bhd 652244161 manufacture(69510-010)