Label: OPRECARE 21- sodium monofluorophosphate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71764-102-01, 71764-102-02 - Packager: O'PRECARE
- 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 October 12, 2017
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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Warnings
When using this product, if irritation occurs stop use and ask a dentist. Do not swallow, and rinse enough after use. Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.
- Uses
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Directions
Directions Adults and children 2 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 physician Children 2 to 6 years Use only a pea sized amount and supervise childs brushing and rinsing (to minimize swallowing) Children under 2 years Ask a dentist or physician - Keep out of reach of children
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Inactive ingredients
Silica, Tocopheryl Acetate, Piridokssin Hydrochloride, Sodium Pyrophosphate, Sorbitol, PEG-32, Hydrated Silica, Cellulose Gum, Titanium Oxide, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Sodium Methyl Cocoyl Taurate, Ubidecarenone, Cnidium Extract, Menthol, Mint Flavor (Fragrance), Chamomilla Recutita (Matricaria) Flower Extract, Peppermint Flavor (fragrance), D.I-WATER
- O'PRECARE 21
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INGREDIENTS AND APPEARANCE
OPRECARE 21
sodium monofluorophosphate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71764-102 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.36 g in 60 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Sorbitol (UNII: 506T60A25R) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) Xylitol (UNII: VCQ006KQ1E) Stevioside (UNII: 0YON5MXJ9P) Hydrated Silica (UNII: Y6O7T4G8P9) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) Menthol (UNII: L7T10EIP3A) LICORICE (UNII: 61ZBX54883) PROPOLIS WAX (UNII: 6Y8XYV2NOF) Allantoin (UNII: 344S277G0Z) PIRIDOCAINE HYDROCHLORIDE (UNII: VG6P406YHV) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Lemon Oil (UNII: I9GRO824LL) Orange Oil (UNII: AKN3KSD11B) Eucalyptus Oil (UNII: 2R04ONI662) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71764-102-02 1 in 1 PACKAGE 10/12/2017 1 NDC:71764-102-01 60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/12/2017 Labeler - O'PRECARE (694604592) Registrant - O'PRECARE (694604592) Establishment Name Address ID/FEI Business Operations O'PRECARE 694604592 relabel(71764-102) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(71764-102)
