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Soulus rp rash and pain - Medication Information

Product NDC Code 65121-100
Drug Name

Soulus rp rash and pain

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride .5 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1010925,
1094831
Application Number M017
Labeler Name Pure Source, LLC
Packages
Package NDC Code Description
65121-100-01 44.36 g in 1 tube (65121-100-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Lidocaine HCl 0.50%

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: Apply directly to effected area. Do not use more than four times per day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Other Ingredients: Other Ingredients: (Organic) Beeswax, Bentonite, Eugenia Caryophyllus (Clove) Flower Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Zinc Oxide, Zingiber Officinale (Ginger) Oil.

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 temporary relief of pain and itching associated with minor skin irritations and/or insect bites. Uses:

Purpose

Information about the drug product’s indications for use.
Purpose Topical Anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
Soulus Rp Rash and Pain LIDOCAINE HYDROCHLORIDE YELLOW WAX BENTONITE CLOVE OIL SILVER OXIDE JOJOBA OIL ZINC OXIDE GINGER OIL LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE

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.
Soulus Rp RASH and PAIN Relieves Skin Irritation and Discomfort NET WT 1.5oz SoulusRp

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 Made in USA . Distributed by PURE SOURCE, Inc. Miami, Fl 33172. ph (305) 477-8111

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, consult physician. Do not bandage tightly.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast feeding, contact physician prior to 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. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinuing use and consult physician. Warnings:

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