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| Product NDC Code | 69396-031 | ||||
|---|---|---|---|---|---|
| Drug Name | Rhuli gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 244443, 1923146 |
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| Application Number | part341 | ||||
| Labeler Name | Trifecta Pharmaceuticals USA, 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 Camphor 0.3%
Active Ingredient Menthol 0.3%
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: Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Benzyl alcohol, Carbomer 940, Isopropyl alcohol, Purified water, 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.Uses Temporarily relieves pain and itching associated with: minor burns scrapes sunburn insect bites minor cuts minor skin irritations rashes due to poison ivy, poison oak, poison sumac
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Rhuli Gel Camphor, Menthol CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CARBOMER 940 ISOPROPYL ALCOHOL MENTHOL MENTHOL BENZYL ALCOHOL WATER TROLAMINE
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.Packaging rhuli gel 2
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
Distributed By: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Ave. Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com
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 immediately.
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 Doctor if: Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store at controlled room temperature 20°-25°C (68°-77°F). Close cap tightly after use Questions: Call 1-888-296-9067
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 For external use only Flammable: Keep away from fire or flame When using this product: avoid contact with eyes
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