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| Product NDC Code | 58400-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Scalp cv68 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 416910 | ||||
| Application Number | M032 | ||||
| Labeler Name | Pharmco Laboratories, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid 3%
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 Use only as directed. Apply to affected areas one to four times daily or as directed by a doctor. Massage well into affected areas. Optimally, this product should be applied to the scalp and left overnight.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, C12-15 Alkyl Benzoate, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Prunus Amigdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Triethanolamine, Water.
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 relief of symptoms associated with seborrheic dermatitis, dandruff, and/or psoriasis, including: itching scaling flaking redness irritation of the skin. Helps prevent recurrence.
Purpose
Information about the drug product’s indications for use.Purpose For the relief of Seborrheic Dermatitis, Dandruff, and/or Psoriasis.
Spl product data elements
Usually a list of ingredients in a drug product.Scalp CV68 Salicylic Acid Salicylic Acid Salicylic Acid CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) BUTYLATED HYDROXYTOLUENE ALKYL (C12-15) BENZOATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE Diazolidinyl Urea EDETATE DISODIUM ANHYDROUS Glycerin Methylparaben Propylene Glycol Propylparaben ALMOND OIL SESAME OIL Sodium Hydroxide SORBITAN MONOOLEATE CUPRIC BIS(TRIETHANOLAMINE) Water
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 - 96 g Bottle Label PHARMCO SKINCARE LABS Scalp Cream Helps Control SEBORRHEIC DERMATITIS, DANDRUFF & PSORIASIS Net wt. 3.4 oz. (96 g) PRINCIPAL DISPLAY PANEL - 96 g Bottle 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
Manufactured by : Pharmco Laboratories, Inc. 3520 South St. • Titusville, FL 32780
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 call a poison control center immediately.
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? call 1.800.635.0712 Monday through Friday 8:00 AM to 4:30 PM
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature.
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 the eyes. If contact occurs, rinse eyes thoroughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a doctor. If condition covers a large area of the body, consult your doctor before using this product. If this product causes increased irritation, discontinue use and seek medical advice. Keep out of reach of children. If swallowed get medical help or call a poison control center immediately.
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