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Product NDC Code | 72839-265 | ||||
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Drug Name | Formula 2 skin care |
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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 | CREAM | ||||
RxCUI drug identifier | 1366789 | ||||
Application Number | part346 | ||||
Labeler Name | Derma Care Research Labs | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine 5.0%
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.When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor. To use finger cots: roll one finger cot over a finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Tocopheryl Acetate, 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 Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.
Purpose
Information about the drug product’s indications for use.Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Formula 2 Skin Care Lidocaine 5% BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYSORBATE 80 CHOLESTEROL HYDROGENATED SOYBEAN LECITHIN ISOPROPYL MYRISTATE PROPYLENE GLYCOL WATER TROLAMINE .ALPHA.-TOCOPHEROL ACETATE 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.Carton
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 the children. If swallowed, get medical help or contact a Poison Control Center right away.
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.For external use only. When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this 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 to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.
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