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| Product NDC Code | 82426-155 | ||||
|---|---|---|---|---|---|
| Drug Name | Hapee fresh green outburst 100 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 1038995 | ||||
| Application Number | part355 | ||||
| Labeler Name | LAMOIYAN CORPORATION | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Sodium Monofluorophosphate: 1.14% w/w (1,500 ppm fluoride as added) (0.15% w/w fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Direction Brush thoroughly, preferably after each meal or at least twice a day. Do not swallow. Rinse and spit out after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Sodium Saccharin, Methylparaben, Mica, Propylparaben, FD&C Red No.40
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use Helps protect against cavities
Purpose
Information about the drug product’s indications for use.Anti-cavity
Spl product data elements
Usually a list of ingredients in a drug product.HAPEE EXPLOSIVE MENTHOL RED 150 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SACCHARIN SODIUM METHYLPARABEN MICA PROPYLPARABEN FD&C RED NO. 40 Characteristic, sweet spicy taste HAPEE FRESH AND COOL WHITE 150 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN ALPHA-TOCOPHEROL ACETATE ALLANTOIN Methanol and spearmint HAPEE FRESH AND COOL WHITE 100 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN ALPHA-TOCOPHEROL ACETATE ALLANTOIN Methanol and spearmint HAPEE GUMTECT GUM CARE SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SACCHARIN SODIUM ALPHA-TOCOPHEROL ACETATE O-CYMEN-5-OL ANHYDROUS DIBASIC CALCIUM PHOSPHATE ALLANTOIN Rich, rounded spearmint with fresh mentholic peppermint HAPEE GUMTECT SENSITIVE 100 SODIUM MONOFLUOROPHOSPHATE SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SACCHARIN SODIUM SODIUM HYDROXIDE SUCRALOSE O-CYMEN-5-OL ALPHA-TOCOPHEROL ACETATE TITANIUM DIOXIDE ALLANTOIN Characteristic, sweet minty taste HAPEE FRESH GREEN OUTBURST 100 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN ALPHA-TOCOPHEROL ACETATE ALLANTOIN POLYETHYLENE GLYCOL 600 CELLULOSE SODIUM PHOSPHATE MICA FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Sweet spicy taste HAPEE FRESH GREEN OUTBURST 150 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN ALPHA-TOCOPHEROL ACETATE ALLANTOIN POLYETHYLENE GLYCOL 600 CELLULOSE SODIUM PHOSPHATE MICA FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Sweet spicy taste HAPEE OUTRAGEOUS BLUE CHILL 150 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN MICA FD&C BLUE NO. 1 sweet spicy taste
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.HAPEE EXPLOSIVE MENTHOL RED 150 EXPLOSIVE_MENTHOL_RED_150_ML
HAPEE FRESH AND COOL WHITE 150 ML FRESH_AND_COOL_WHITE_150ML
HAPEE FRESH AND COOL WHITE 100ML FRESH_AND_COOL_WHITE_100_ML
HAPEE GUMTECT GUM CARE HAPEE GUMTECT GUM CARE
HAPEE GUMTECT SENSITIVE 150 GUMTECT_SENSITIVE
HAPEE FRESH GREEN OUTBURST 100ML FRESH_GREEN_OUTBURST_100ML
HAPEE FRESH GREEN OUTBURST 150 ML FRESH_GREEN_OUTBURST_150ML
HAPEE OUTRSGEOUS BLUE CHILL OUTRAGEOUS_BLUE_CHILL_150_ML
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.PRODUCT SPECIFICATIONS
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Warning Keep out of reach of children
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS AND PRECAUTIONS SECTION Children of six years and younger: Use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources, consult a dentist or doctor.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API