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| Product NDC Code | 61577-3242 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Re-leve |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| Application Number | part348 | ||||||
| Labeler Name | SOMBRA COSMETICS | ||||||
| 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 Ingredients Menthol USP 6%
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 Adult and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub until gel is absorbed, children under 2 years of age: consult your doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, emu oil, citrus aurantium dulcis (orange) peel oil, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, sodium hydroxymethylglycinate
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 minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains
Purpose
Information about the drug product’s indications for use.Purpose Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.RE-LEVE MENTHOL ALOE VERA LEAF CARBOXYPOLYMETHYLENE DECYL GLUCOSIDE WATER CITRUS MAXIMA SEED GREEN TEA LEAF FILIPENDULA ULMARIA FLOWER ROSA DAMASCENA FLOWER OIL SODIUM CARBONATE GLYCERIN HAMAMELIS VIRGINIANA LEAF YUCCA SCHIDIGERA ROOT LEMON OIL PHENOXYETHANOL CAPRYLYL GLYCOL MENTHOL MENTHOL
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.image description
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Orders: Call toll-free: 1-844-303-0037, 155 NE Court St.-152, Prineville, OR, 97754. www.allforu.org. Alcohol-free product made in USA.
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 Keep out of reach of children . For external use only. Avoid contact with eyes and mucous membranes, wounds or damaged skin. Do not use with heating pads. Stop uses and ask a doctor if: Conditions worsen, symptoms persist for more than 7 days, symptoms clear up and occur again 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