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| Product NDC Code | 58443-0411 | ||||
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| Drug Name | H plus holdings nourishing |
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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 | SHAMPOO | ||||
| Application Number | part348 | ||||
| Labeler Name | Prime Enterprises, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Hydrocortisone acetate 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 Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients
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 and rashes.
Purpose
Information about the drug product’s indications for use.Purpose Antipuritic (Anti-Itch)
Spl product data elements
Usually a list of ingredients in a drug product.H Plus Holdings Nourishing Hydrocortisone Acetate HYDROCORTISONE HYDROCORTISONE BENZYL ALCOHOL CITRIC ACID MONOHYDRATE ISOPROPYL PALMITATE MENTHOL WATER BUTYLENE GLYCOL COCAMIDOPROPYL BETAINE DECYL GLUCOSIDE LECITHIN, SOYBEAN POLOXAMER 407 WILLOW BARK PSEUDOPTEROGORGIA ELISABETHAE SODIUM LAUROAMPHOACETATE BUTYLATED HYDROXYTOLUENE 4-TERPINEOL, (+/-)- ALLANTOIN RHODODENDRON FERRUGINEUM LEAF METHYLPROPANEDIOL SODIUM LAUROYL METHYL ISETHIONATE PHENOXYETHANOL SALICYLIC ACID SODIUM COCOYL ISETHIONATE SODIUM METHYL COCOYL TAURATE LACTIC ACID SODIUM HYDROXIDE ISOMALT ETHYLHEXYLGLYCERIN GLYCERETH-26 GLYCERIN GLYCOL STEARATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) EDETATE DISODIUM ANHYDROUS MEDIUM-CHAIN TRIGLYCERIDES White Pearl
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.Hair Sanity Anti-Itch Shampoo Step 1 Principle Display Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of 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. Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.
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.Avoid contact wih the eyes. If contact occurs, rinse eyes thoroughly with water.
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