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Product NDC Code | 72663-493 | ||||
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Drug Name | Itch fixer |
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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 | part348 | ||||
Labeler Name | Welly Health PBC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrocortisone 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.Directions Adults and children 2 years and older: • apply to affected area not more than 3 to 4 times daily. Children under 2 years of age • do not use. Consult a doctor. For external anal itching • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years with external anal itching: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua, Aloe Vera Oil, Benzoic Acid, Cetostearyl Alcohol, Glyceryl Stearate, Jojoba Oil, Polysorbate 80, Oleyl Alcohol, Sorbic Acid, Sorbitan Monooleate
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 For temporary relief of itching associated with minor skin irritations and rashes due to • eczema • insect bites • poison ivy • poison oak • poison sumac • soaps • detergents • cosmetics • jewelry • seborrheic dermatitis • psoriasis • external feminine, genital and anal 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.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Itch Fixer hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER ALOE VERA LEAF BENZOIC ACID CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE JOJOBA OIL POLYSORBATE 80 OLEYL ALCOHOL SORBIC ACID SORBITAN MONOOLEATE
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.Packaging IMAGE
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
1% Hydrocortisone Anti-Itch Cream FREE FROM x Petrolatum Parabens Sulfates Mineral Oil Fragrance FRAGRANCE FREE KID FRIENDLY MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING SQUEAKY CLEAN FIRST AID Formulated with naturally derived plant-based ingredients ALOE VERA known to help soothe skin JOJOBA OIL known to help moisturize skin HELPS PROVIDE TEMPORARY ITCH RELIEF FROM skin irritation rashes insect bites poison ivy eczema Packaging is recyclable. Distributed by Welly Health PBC Minneapolis, MN 55402 1-833-BE-WELLY | getwelly.com Product of USA and Canada with globally sourced materials.
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 the reach of children. • Do not use if pregnant or breastfeeding.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at a controlled room temperature 68°–77°F (20°–25°C).
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 • for external genital itching – if you have a vaginal discharge, consult a doctor. When using this product • avoid contact with eyes • do not begin the use of any other hydrocortisone product unless you have consulted a doctor • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult 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 • condition worsens • If symptoms persist for more than 7 days or clear up and reoccur, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor. Keep out of the reach of children. • Do not use if pregnant or breastfeeding.
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