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| Product NDC Code | 70288-714 | ||||
|---|---|---|---|---|---|
| Drug Name | Ana cool rapid soothing cooling formula |
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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 | CREAM | ||||
| RxCUI drug identifier | 106258 | ||||
| Application Number | M017 | ||||
| Labeler Name | Ana-Cool, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Hydrocortisone 1.0% Anti -itch
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: cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before the applicationof this product Adults: apply to the affected area not more than 3 to 4 times daily. Adults and children 12 years of age and older: do not use, consult a doctor Children under 12 years of age:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, cetearcth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.
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 relief of external anal itching Temporary relief of itching associated with minor skin irritations and rashes 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.Anti -itch
Spl product data elements
Usually a list of ingredients in a drug product.Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE WATER ALKYL (C12-15) BENZOATE GREEN TEA LEAF CETOSTEARYL ALCOHOL CETYL ALCOHOL ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE HAMAMELIS VIRGINIANA TOP SUNFLOWER OIL ALOE VERA LEAF PEG-100 STEARATE PETROLATUM PHENOXYETHANOL STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE HYDROCORTISONE HYDROCORTISONE
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.Package Labeling: 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
Other Information Store at 20 - 25 °C (68-77°F)
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 for the treatment of diaper rash. Consult a doctor.
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 Centre 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 • bleeding occurs • condition worsen • symptoms persist for more than 7 days or clear up occur again within a few days. 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 the eyes • do not exceed the recommended daily dosage unless directed by a doctor • do not put 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. Do not use for the treatment of diaper rash. Consult a doctor. When using this product, • avoid contact with the eyes • do not exceed the recommended daily dosage unless directed by a doctor • do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • bleeding occurs • condition worsen • symptoms persist for more than 7 days or clear up occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre 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