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| Product NDC Code | 59062-3301 | ||||
|---|---|---|---|---|---|
| Drug Name | Babyganics soothing 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 | STICK | ||||
| RxCUI drug identifier | 1745093 | ||||
| Application Number | M016 | ||||
| Labeler Name | KAS Direct, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Colloidal oatmeal 10%
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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients helianthus annuus (sunflower) seed oil Certified Organic Ingredient. Unless otherwise specified, product not labeled as organic. , cera alba (beeswax) , cocos nucifera (coconut) oil , ricinus communis (castor) seed oil , butyrospermum parkii (shea) butter , calendula officinalis (calendula) flower oil , mentha piperita (peppermint) oil, tocopherol, solanum lycopersicum (tomato) seed oil, lavandula angustifolia (lavender) oil, anthemis nobilis (chamomile) oil,vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil , rubus idaeus (red raspberry) seed 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 temporarily protects and helps relieve minor skin irritation and itching due to: insect bites rashes poison ivy, oak or sumac
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.Babyganics Soothing Itch OATMEAL OATMEAL OATMEAL SUNFLOWER SEED WHITE WAX COCONUT OIL CASTOR OIL SHEA BUTTER CALENDULA OFFICINALIS FLOWER PEPPERMINT OIL Tocopherol TOMATO SEED OIL LAVENDER OIL CHAMAEMELUM NOBILE FLOWER OIL CRANBERRY SEED OIL NIGELLA SATIVA SEED OIL RASPBERRY SEED OIL
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 - 18 g Stick Carton babyganics ® soothing itch stick skin protectant colloidal oatmeal* helps relieve irritation caused by insect bites & rashes made without parabens, phthalates, cortisone, steroids, dyes, fragrances Discover which of our ingredients are certified organic on the back panel. NET WT 0.64 OZ (18 g) PRINCIPAL DISPLAY PANEL - 18 g Stick Carton
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
Dist. by KAS Direct, LLC 1525 Howe Street Racine, WI 53403
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 symptoms last 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 do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 59-77°F (15-25°C) keep carton for complete information
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 Stop use and ask a doctor if condition worsens symptoms last 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