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| Product NDC Code | 83987-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Sugardoh ouchie relief roller |
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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 | ||||
| RxCUI drug identifier | 1652104 | ||||
| Application Number | M015 | ||||
| Labeler Name | Sugardoh LLC | ||||
| 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 5%w/w
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 When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older : Apply to the affected area up to 6 times a day. Children under 12 years of age : Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Camellia Sinensis Leaf Extract, Citral, Denatonium benzoate, Fragrance, Hexyl Cinnamal, Isopulegol, Limonene, Linalool, Menthoxypropanediol, PVP, t-Butyl Alcohol, 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 temporarily relieves pain and itching due to anorectal disorders
Purpose
Information about the drug product’s indications for use.Purpose Local anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Sugardoh Ouchie Relief Roller Lidocaine ALOE VERA LEAF BENZYL ALCOHOL .ALPHA.-HEXYLCINNAMALDEHYDE 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL TERT-BUTYL ALCOHOL WATER DENATONIUM BENZOATE GREEN TEA LEAF CITRAL ISOPULEGOL POVIDONE ALCOHOL LIMONENE, (+)- LINALOOL, (+)- LIDOCAINE LIDOCAINE
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.Product Packaging 1
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
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.
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 USP controlled room termperature 20º - 25º C (68º - 77ºF)
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 [email protected] (737) 295-9222
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 rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return 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 eyes do not exceed recommended dosage unless directed by a doctor do not put htis product into the rectum by using fingers or any mechanical device or applicator.
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 When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put htis product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return within a few days Keep out of reach of children.
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