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| Product NDC Code | 83324-019 | ||||
|---|---|---|---|---|---|
| Drug Name | Maximum otc strength feminine anti-itch creme |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 637518 | ||||
| Application Number | M017 | ||||
| Labeler Name | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | ||||
| 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.Drug Facts Active ingredients Benzocaine 20% Resorcinol 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.Do not apply Directions Do not apply over large area of the body. adults and children 12 years and older: apply a fingertip amount (approximately 1-inch strip) to the affected area not more than 3 to 4 times daily children under 12 years: do not use; consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe vera leaf, alpha-tocopherol, butylated hydroxytoluene, carbomer, cetyl alcohol cholecalciferol, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, mineral oil, PEG 100 stearate, PEG 4000, phenoxy ethanol, propylene glycol, sodium hydroxide, sodium lauryl sulfate, trisodium edta, vitamin A palmitate, 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.Use temporarily relieves itching
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Maximum OTC Strength Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL ALCOHOL CHOLECALCIFEROL GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE ISOPROPYL PALMITATE ISOPROPYL STEARATE BUTYLATED HYDROXYTOLUENE POLYETHYLENE GLYCOL 4000 MINERAL OIL PEG-100 STEARATE PROPYLENE GLYCOL WATER ALOE VERA LEAF VITAMIN A PALMITATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE ALPHA-TOCOPHEROL EDETATE TRISODIUM BENZOCAINE BENZOCAINE RESORCINOL RESORCINOL PHENOXYETHANOL
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.Quality Choice Maximum OTC Strength Feminine Anti-itch Creme Pack
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 Poison Control Center right away. (1-800-222-1222)
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at 20° -25° C (68° -77° F)
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? 1-866-326-1313
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, or if symptoms persist for more than7 days or clear up and occur again within a few days
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 the eyes
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