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| Product NDC Code | 41250-259 | ||||
|---|---|---|---|---|---|
| Drug Name | Meijer max. strength anti-itch cream intensive healing 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 | part348 | ||||
| Labeler Name | MEIJER, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Hydrocortisone 1%..............................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.Other Information store at room temperature 20-25ºC (68-77ºF)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera leaf, .alpha.-tocopherol acetate, benzyl alcohol, cetyl alcohol, dimethicone 350, edetate disodium, gelatin hydrolysate, glycerin, glyceryl stearate/peg-100 stearate, magnesium ascorbyl phosphate, matricaria chamomilla flowering top, menthyl lactate, methyl gluceth-20, methylparaben, pretrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, steareth-2, steareth-21, stearyl alcohol, vitamin a palmitate
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.Directions for itching of skin irritation, 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: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis jewelry insect bites soaps cosmetics detergents seborrheic dermatitis poison ivy, oak sumac temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Spl product data elements
Usually a list of ingredients in a drug product.Meijer Max. Strength Anti-Itch Cream Intensive Healing Formula Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF MAGNESIUM ASCORBYL PHOSPHATE MENTHYL LACTATE, (-)- METHYLPARABEN POLYSORBATE 60 STEARETH-21 PROPYLENE GLYCOL WATER VITAMIN A PALMITATE DIMETHICONE 350 GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) CETYL ALCOHOL EDETATE DISODIUM GLYCERYL STEARATE/PEG-100 STEARATE METHYL GLUCETH-20 .ALPHA.-TOCOPHEROL ACETATE GLYCERIN BENZYL ALCOHOL PETROLATUM STEARETH-2 STEARYL ALCOHOL MATRICARIA CHAMOMILLA FLOWERING TOP PROPYLPARABEN
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.234-57
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 in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. more than directed unless directed by 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 (1-800-222-1222) 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 condition worsens, symptoms persist 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 asked a doctor rectal 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 avoid contact with eyes do not put directly 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.
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
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