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| Product NDC Code | 69618-075 | ||||
|---|---|---|---|---|---|
| Drug Name | Retalief lidocaine 5 |
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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 | M017 | ||||
| Labeler Name | Reliable 1 Laboratories 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.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, cleanse the affected 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 of age and older: apply externally to the affected area not more than 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.Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine.
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.helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders
Purpose
Information about the drug product’s indications for use.Local Anesthetic Anorectal (Hemorrhoidal) Cream
Spl product data elements
Usually a list of ingredients in a drug product.RETALIEF LIDOCAINE 5 LIDOCAINE TOCOPHEROL LIDOCAINE LIDOCAINE BENZYL ALCOHOL ALOE BARBADENSIS LEAF JUICE CHOLESTEROL ISOPROPYL MYRISTATE MINERAL OIL PROPYLENE GLYCOL TROLAMINE POLYSORBATE 80 WATER CARBOMER
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.NDC 69618-075-78 Reliable 1 Laboratories Rectalief Anorectal Cream Lidocaine 5% Relieves Pain, Itching & Burning Highest Strength of Non-Rx Lidocaine Available 1OZ (30gm) QUESTIONS 1-516-341-0666 Monday- Friday Distributed by Reliable 1 Labs 99 W. Hawthorne Ave #610 Valley Stream, NY 11580 www.reliable1labs.com Made in China Carton rectalief Tube
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, get medical help or contact a Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store between 20°-25° C (68°-77° F)
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 an allergic reaction occurs symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms 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 eyes do not use more than directed unless directed by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before 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.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