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| Product NDC Code | 73557-133 | ||||
|---|---|---|---|---|---|
| Drug Name | Overnight relief gel-patch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | M017 | ||||
| Labeler Name | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | ||||
| 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 Menthol 5% w/w ...... Purpose: 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 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily. • children under 12 years of age: consult a physician • wash hands after use with cool water
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.Dosage forms & strengths This is patch dosage form. The active ingredient strength is 5%.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Mineral Oil, Lavender Essential Oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Kaolin, Carboxymethylcellulose Sodium, Titanium Dioxide, L-Tartaric Acid, Benzalkonium Chloride, Lauralkonium Chloride
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 Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthrits strains bruises sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.OVERNIGHT RELIEF Gel-Patch Menthol KAOLIN TARTARIC ACID WATER DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS PROPYLENE GLYCOL POLYACRYLIC ACID (250000 MW) CARBOXYMETHYLCELLULOSE SODIUM SODIUM POLYACRYLATE (2500000 MW) TITANIUM DIOXIDE MINERAL OIL PETROLATUM BENZALKONIUM CHLORIDE LAURALKONIUM CHLORIDE POLYSORBATE 80 GLYCERIN POVIDONE K90 LAVENDER OIL EDETATE DISODIUM MENTHOL MENTHOL
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 label. Principal display panel 01 05
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.Ask doctor Stop use and ask a doctor if: • you experience pain, swelling or blistering of the skin • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • arthritic pain persists for more than 10 days, or redness is present If pregnant or breastfeeding, ask a health professional before use.
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 • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device
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 accidentally ingested, get medical help or contact 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 Questions or comments : 86-21-31166566
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 Stop use and ask a doctor if : Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 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 When using this prudocts: • use only as directed • avoid contact with eyes or on mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy or breast feeding If pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 20-25℃ (68-77℉) • store in a cool dry place away from direct sunlight
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 When using this prudocts : • use only as directed • avoid contact with eyes or on mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device Stop use and ask a doctor if: • you experience pain, swelling or blistering of the skin • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • arthritic pain persists for more than 10 days, or redness is present If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If accidentally ingested, get medical help or contact 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