Label: OPRECARE 12- silicon dioxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71764-101-01, 71764-101-02 - Packager: O'PRECARE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated October 11, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
Tocopheryl Acetate, Sorbitol, PEG-32, Cellulose Gum, Hydrated Silica, Stevioside, Xylitol, Sodium Methyl Cocoyl Taurate, Hydroxylapatite, Calcium Carbonate, Propolis Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (SAGE) Extract, Pomegranate Extract, Spearmint Flavor (fragrance), Lemon Flavor (fragrance), Orange Oil, Menthol, Mastic Oil, D.I-WATER
- O'PRECARE 12
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INGREDIENTS AND APPEARANCE
OPRECARE 12
silicon dioxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71764-101 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 1.71 g in 60 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) HYDRATED SILICA (UNII: Y6O7T4G8P9) STEVIOSIDE (UNII: 0YON5MXJ9P) Xylitol (UNII: VCQ006KQ1E) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Calcium Carbonate (UNII: H0G9379FGK) PROPOLIS WAX (UNII: 6Y8XYV2NOF) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL) POMEGRANATE (UNII: 56687D1Z4D) ORANGE OIL (UNII: AKN3KSD11B) Menthol (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71764-101-02 1 in 1 PACKAGE 10/12/2017 1 NDC:71764-101-01 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 unapproved drug other 10/12/2017 Labeler - O'PRECARE (694604592) Registrant - O'PRECARE (694604592) Establishment Name Address ID/FEI Business Operations O'PRECARE 694604592 relabel(71764-101) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(71764-101)
