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| Product NDC Code | 58443-0550 | ||||
|---|---|---|---|---|---|
| Drug Name | Frida mom healing foam |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| Application Number | part346 | ||||
| Labeler Name | Prime Enterprises, 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 ingredients Witch Hazel 50%
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: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Add foam on top of pad or pad liner. Children under 12 years of age: consult a doctor. Apply to the affected area up to 6 times daily or after each bowel movement.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Hamamelis Virginiana (Witch Hazel) Extract, Water, Glycerin, Alcohol, Sodium Lauroamphoacetate, Phenoxyethanol, Benzoic Acid, Tocopherol, Sodium Benzoate, Dehydroacetic Acid, Caprylic/Capric Triglyceride, Sodium Citrate, Mentha Piperita (Peppermint) Oil, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid
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 Helps relieve the local itching and discomfort in the perianal area.
Purpose
Information about the drug product’s indications for use.Purpose Astringent
Spl product data elements
Usually a list of ingredients in a drug product.Frida Mom Healing Foam Salicylic Acid CITRIC ACID MONOHYDRATE MEDIUM-CHAIN TRIGLYCERIDES SODIUM CITRATE PEPPERMINT OIL CHAMOMILE SODIUM BENZOATE HAMAMELIS VIRGINIANA TOP GLYCERIN ALCOHOL DEHYDROACETIC ACID SODIUM LAUROAMPHOACETATE PHENOXYETHANOL BENZOIC ACID TOCOPHEROL WITCH HAZEL WITCH HAZEL Very Light 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.Frida mom Perineal Healing Foam Principle Display Label
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature
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 Rectal bleeding occurs. Condition worsens or does not improve within 7 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 eyes. If contact occurs, rinse thoroughly with water. Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator.
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 eyes. If contact occurs, rinse thoroughly with water. Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if Rectal bleeding occurs. Condition worsens or does not improve within 7 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