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| Product NDC Code | 61010-5800 | ||||||||
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| Drug Name | Hydrocortisone |
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| Type | Generic | ||||||||
| 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 | Safetec of America, Inc. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrocortisone 1.0%
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 adults and children 2 years of age and older: apply to affected area 3 to 4 times daily children under 2 years of age: do not use, consult a doctor adults for external anal itching when practical, cleanse the affected area with mild soap and 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 children under 12 years of age: for external anal itching, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax
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, seborrheic dermatitis, psoriasis and scrapes 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.Hydrocortisone Hydrocortisone ALCOHOL METHYLPARABEN MINERAL OIL PARAFFIN PETROLATUM PROPYLPARABEN WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 PEG-150 DISTEARATE STEARETH-20 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.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label Safetec 1% Hydrocortisone Cream™ 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label
PRINCIPAL DISPLAY PANEL – Box Label NDC 61010-5800-2 Safetec First Aid 1% Hydrocortisone Cream For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation, or Rashes Reorder no. 53110 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com PRINCIPAL DISPLAY PANEL – Box Label
PRINCIPAL DISPLAY PANEL – 10 Packet Box Label Safetec ® FIRST AID Hydrocortisone Cream 1% Hydrocortisone for relief from itching, inflammation, and rashes 10 Packets Each Packet Net Wt. 0.9g Made in USA Reorder no. 53108 PRINCIPAL DISPLAY PANEL – 10 Packet Box 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 room temperature (do not freeze) do not use any opened or torn packets
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 in eyes for feminine itching if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with any other Hydrocortisone product unless you have consulted 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.
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? 1-800-456-7077 Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 . 800-456-7077 www.safetec.com
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 in eyes for feminine itching if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with 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 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