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| Product NDC Code | 72400-300 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Superbalm |
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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 | SALVE | ||||||
| Application Number | M006 | ||||||
| Labeler Name | Era Organics, 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.Superbalm Healing Ointment for Babies Colloidal Oatmeal 1%
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.Superbalm Healing Ointment for Babies Apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Superbalm Healing Ointment for Babies Castor (Ricinus Communis) Oil*, Chickweed (Stellaria Media)* & Chamomile (Matricaria Recutita)* Infusion in Sunflower (Helianthus Annuus) Oil*, Beeswax (Cera Alba), Cocoa Butter (Theobroma Cacao), Vegetable Glycerin*, Coconut (Cocos Nucifera) Oil*, Calendula (Calendula Officinalis) Flower Extract*, Tapioca Starch*, Avocado (Persea Gratissima) Oil*, Rosehip (Rosa Canina) Oil*, Arnica (Arnica Montana) Oil*, Non-GMO Vitamin E from Sunflowers*, Organic Ingredients.
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.Superbalm Healing Ointment for Babies Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema - Rashes
Purpose
Information about the drug product’s indications for use.Superbalm Healing Ointment for Babies Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Superbalm Colloidal Oatmeal 1% OATMEAL OATMEAL Characteristic salve color
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.Superbalm Healing Ointment for Babies Superbalm Healing Ointment for Babies
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Superbalm Healing Ointment for Babies 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
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.Superbalm Healing Ointment for Babies Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.Superbalm Healing Ointment for Babies For external use only. When using this product do not get into eyes
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