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| Product NDC Code | 82186-155 | ||||
|---|---|---|---|---|---|
| Drug Name | Zaxs original bug bite and itch |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1595494 | ||||
| Application Number | M016 | ||||
| Labeler Name | Zax Healthcare Inc. | ||||
| 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 Ingredien t Colloidal Oatmeal 5%
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 •Apply as needed. •As soon as bug bite itching occurs.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Alcohol Arnica Montana Flower Extract Caprylic/Capric Glycerides Caprylyl Glycol Ceteareth-20 Cetearyl Alcohol Cetyl Alcohol Citric Acid Cocos Nucifera (Coconut) Oil Glycerin Glyceryl Stearate Glycine Soja (Soybean) Oil Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract Melaleuca Alternifolia (Tea Tree) Leaf Oil Menthol Phenoxyethanol Sorbic Acid Tocopherol Water Xanthum Gum
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 Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac, and insect bites.
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Zaxs Original Bug Bite and Itch Colloidal Oatmeal ARNICA MONTANA FLOWER POLYOXYL 20 CETOSTEARYL ETHER COCONUT OIL MENTHOL PHENOXYETHANOL SORBIC ACID TOCOPHEROL CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE OATMEAL OATMEAL ALCOHOL CAPRYLYL GLYCOL CETYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE SOYBEAN OIL WITCH HAZEL MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL WATER XANTHAN GUM 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.Tube 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 Colloidal Oatmeal 5%
Other Information Store at room temperature.
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 the reach of children Keep out of the reach of children. If swallowed, consult a Poison Control Centre immediately.
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 do not get into eyes or mucous membranes. If this occurs, rinse thoroughly with water. •If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. •Stop use if: •irritation develops. •If you are allergic to any ingredient in this product. •If hypersensitivity occurs consult a 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