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Sombra plus cbd 1000mg cool therapy - Medication Information

Product NDC Code 61577-7100
Drug Name

Sombra plus cbd 1000mg cool therapy

Type Brand
Active Ingredients
Menthol .06 g/g
Route TOPICAL
Dosage Form GEL
Application Number part348
Labeler Name Sombra Cosmetics Inc.
Packages
Package NDC Code Description
61577-7100-2 56.7 g in 1 jar (61577-7100-2)
61577-7100-4 113.4 g in 1 jar (61577-7100-4)
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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