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| Product NDC Code | 53997-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Lansinoh pain relieving |
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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 | SPRAY | ||||
| RxCUI drug identifier | 1869797 | ||||
| Application Number | M017 | ||||
| Labeler Name | Lansinoh Laboratories Inc | ||||
| 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.DRUG FACTS Active Ingredient Purpose Lidocaine 4% Topical Analgesic
| Active Ingredient | Purpose |
| Lidocaine 4% | 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 ■ For adult use only ■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water. Distributed By: Lansinoh Laboratories, Inc Alexandria, VA 22314, USA Tel: +1-800-292-4794 | www.lansinoh.com
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.For external use only
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.Lansinoh Pain Relieving Lidocaine HCL PHYTATE SODIUM ALOE VERA WHOLE PEG-40 CASTOR OIL EUGENOL ALCOHOL WITCH HAZEL WATER LIDOCAINE LIDOCAINE SODIUM BENZOATE POLOXAMER 188 POTASSIUM SORBATE ALMOND OIL PEPPERMINT OIL CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 2300 MPA.S AT 1%) LAVENDER OIL
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.Lidocaine Carton Lidocaine Label
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.STOP USE AND ASK A DOCTOR Stop use and ask a doctor if ■ Condition worsens ■ Symptoms persist for more than 7 days ■ Symptoms clear up and return within a few day
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 KEEP OUT OF REACH OF CHILDREN. Do not use on infants or children under 12.
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 ■ Condition worsens ■ Symptoms persist for more than 7 days ■ Symptoms clear up and return within a few days
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