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| Product NDC Code | 10237-774 | ||||
|---|---|---|---|---|---|
| Drug Name | Rephresh cooling |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M017 | ||||
| Labeler Name | Church & Dwight Co., 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.Hydrocortisone 0.5%
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.Pump 3-5 times before first use for proper dispensing Shake gently before applying Holding tube 6 inches away from vaginal are and apply using 1 quick, firm spray. Note: Tube is designed to spray upside down, if needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Propanediol, Propylene Glycol, Pentylene Glycol, Laureth-9, Polysorbate 20, Chamomilla Recutita (Matricaria) Flower Extract, Menthyl Ethylamido Oxalate, Citronellyl Methylcrotonate, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Lactic 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.USE For the temporary relief of external feminine itching Other uses of this product should be only under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.External Analgesic/Anti-Itch
Spl product data elements
Usually a list of ingredients in a drug product.Rephresh Cooling Hydrocortisone HYDROCORTISONE HYDROCORTISONE MATRICARIA CHAMOMILLA WHOLE CITRONELLYL METHYLCROTONATE WATER ALOE VERA LEAF PENTYLENE GLYCOL LACTIC ACID, UNSPECIFIED FORM POLIDOCANOL PROPANEDIOL MENTHYL ETHYLENE GLYCOL CARBONATE, (-)- PROPYLENE GLYCOL MATRICARIA CHAMOMILLA FLOWERING TOP POLYSORBATE 20
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.RepHresh™ Vaginal Anti-Itch Spray Cooling Relief Spray #1 Trusted Brand Gynecologist Recommended Unscented 0.50 FL OZ (15mL) 0.5% Hydrocortisone RepHresh Spray.jpg
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Consult a doctor if you are allergic to any ingredient in this product
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use more than directed unless told to do so by a doctor
Instructions for use
Information about safe handling and use of the drug product.Directions Adults and children under 12 years of age and older: Apply to affected area not more than 3 to 4 times daily Children under 12 years of age: Do not use, consult a doctor When practical, cleanse and dry the affected area before application of this product Remove safety seal and cap
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.Keep away from hear or direct sunlight, store at room temperature Do not use if safety seal is broken or missing
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call us at 800 833 9532 Monday through Friday 9 to 5 pm ET or visit our website at www rephresh com
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 persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor
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
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.Warning(s) For external vaginal use only Do not use if you have vaginal discharge
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