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Product NDC Code | 52412-350 | ||||
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Drug Name | Chiggerex |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part348 | ||||
Labeler Name | Randob Labs,Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzocaine 10.0%
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.Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Ascorbic Acid, Camphor, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Diazolidinyl Urea, Disodium EDTA, Eugenia Caryophyllus (Clove) Flower Oil, Fragrance,Mentha Piperita (Peppermint) Oil, Methylparaben, Octyldodecanol, Olea Europaea (Olive) Fruit Extract, PEG-2 Stearate, PEG-2 Stearate SE, PEG-8 Dimethicone, Propylene Glycol, Propylparaben, Pyridoxine HCl, Retinyl Palmitate, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Tocopheryl Acetate, Water, Zea Mays (Corn) Oil
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.Uses temporary relief of pain and itching due to chigger bites red bug bites ticks mosquito bites
Purpose
Information about the drug product’s indications for use.Purpose Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Chiggerex Benzocaine Benzocaine Benzocaine Ascorbic Acid ALOE VERA LEAF CAMPHOR, (-)- CHAMOMILE Cholecalciferol Diazolidinyl Urea EDETATE DISODIUM ANHYDROUS CLOVE OIL PEPPERMINT OIL Methylparaben Octyldodecanol BLACK OLIVE PEG-2 Stearate PEG-8 Dimethicone Propylene Glycol Propylparaben PYRIDOXINE HYDROCHLORIDE VITAMIN A PALMITATE SILICON DIOXIDE Sodium Propoxyhydroxypropyl Thiosulfate Silica .ALPHA.-TOCOPHEROL ACETATE, D- Water CORN OIL Off-White to Yellow
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.PRINCIPAL DISPLAY PANEL - 50 g Jar Label THE ORIGINAL Chiggerex ® 2X Power! with 10% Benzocaine MEDICATED OINTMENT FOR CHIGGER, TICK AND ALL BUG BITES FAST, SOOTHING RELIEF With ALOE VERA Plus CHAMOMILE NET WT. 1.75 OZ. (50g) PRINCIPAL DISPLAY PANEL - 50 g Jar Label
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.Drug Facts
Distributed by: Randob Labs, Ltd. Box 440, Cornwall, NY 12518
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.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes
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 For external use only. When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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