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| Product NDC Code | 69233-843 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Syren intimate relief |
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| Type | Brand | ||||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | Icon Health Science | ||||||||
| 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 Ingredient: Lidocaine HCl 4.00% Topical Analgesic
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: Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under twelve-years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Benzoic Acid, Cannabis Sativus (Hemp) Seed Oil, Carbomer, Carrageenan, Ethylhexylglycerin, I-Arginine, PEG-8, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tocopherol Acetate (Vitamin E), Triethanolamine.
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.Indications: For the temporary relief of pain and itching, cuts, scrapes, and minor skin irritations.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.SYREN Intimate Relief LIDOCAINE HYDROCHLORIDE ALOE VERA LEAF WATER ARNICA MONTANA FLOWER BENZOIC ACID CANNABIS SATIVA SEED OIL CARRAGEENAN ETHYLHEXYLGLYCERIN PHENOXYETHANOL POLYSORBATE 20 PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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.Package Labeling: 1oz/30ml NewCarton InnerLabel
Package Labeling: 1oz/30ml Outer Package01 Inner Package01
Package Labeling: 2.5oz/74ml Outer Package002 Inner Package002
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
Additional Information: Store at room temperature.
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 apply to wounds or damaged skin. Wash hands after use.
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, consult physician.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, contact physician prior to 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. Avoid contact with eyes. If symptoms persist for more than seven days discontinue use. Keep out of reach of children. If swallowed, consult physician. Do not apply to wounds or damaged skin. Wash hands after use. If pregnant or breast feeding, contact physician prior to use.
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