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| Product NDC Code | 61577-7100 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sombra plus cbd 1000mg cool therapy |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Sombra Cosmetics 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.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 adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe barbadensis leaf juice, camellia sinensis (green tea) leaf extract, Cannabidiol (isolate), caprylyl glycol, carbomer, citrus grandis (grapefruit) seed extract, citrus limon (lemon) peel oil, decyl glucoside, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbonate, Filipendula ulmaria (queen of the prairie) flower extract, yucca schidigera root extract,
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: 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.SOMBRA PLUS CBD 1000MG COOL THERAPY MENTHOL ALOE VERA LEAF CARBOMER HOMOPOLYMER TYPE C DECYL GLUCOSIDE WATER GRAPEFRUIT SEED OIL GREEN TEA LEAF FILIPENDULA ULMARIA FLOWER ROSA CENTIFOLIA FLOWER OIL SODIUM CARBONATE GLYCERIN WITCH HAZEL YUCCA SCHIDIGERA ROOT LEMON OIL PHENOXYETHANOL CAPRYLYL GLYCOL CANNABIDIOL 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.label
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 1-800-225-3963
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. Do not use on wounds or damaged skin or with heat source. If you are pregnant or breastfeeding, consult a healthcare professional before use. When using this product: Avoid bandaging tightly, avoid contact with eyes, keep out of reach children
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