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| Product NDC Code | 70000-0543 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader hydrocortisone with aloe |
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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 | LEADER | ||||
| 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 For itching associated with minor skin irritations, inflammation, and rashes: Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor For external anal and genital itching: Adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product apply to affected area not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA
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 the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry and for external anal and genital itching.
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic (anti-itch)
Spl product data elements
Usually a list of ingredients in a drug product.LEADER HYDROCORTISONE WITH ALOE HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL DMDM HYDANTOIN GLYCERYL MONOSTEARATE ISOPROPYL ALCOHOL METHYLPARABEN MINERAL OIL POLYSORBATE 20 PROPYLPARABEN WATER STEARIC ACID TROLAMINE EDETATE TRISODIUM
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.PRINCIPAL DISPLAY PANEL - 28 g Tube Carton NDC 70000-0543-1 LEADER ™ Maximum Strength Hydrocortisone Cream with Aloe Hydrocortisone, 1% | Anti-Itch COMPARE TO CORTIZONE-10® WITH ALOE MAXIMUM STRENGTH active ingredient* 100% Money Back Guarantee Fast Itch Relief Relief in a Soothing Cream • Eczema • Insect Bites • Psoriasis • Poison Ivy, Oak & Sumac • Seborrheic Dermatitis • Soaps • And More NET WT 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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
DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
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 if you have a vaginal discharge. 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 Center right away: 800-222-1222.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 866-323-0107 or www.natureplex.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 persist for more than 7 days or clear up and occurs again within a few days bleeding occurs
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 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 15 to 30°C (59 to 86°F). Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
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. Avoid contact with eyes. Do not use if you have a vaginal discharge. Consult a doctor. When using this product 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 condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days bleeding occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
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