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Product NDC Code | 82026-612 | ||||
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Drug Name | Pluscbd sport recovery stick 1oz |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part348 | ||||
Labeler Name | CV Sciences, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Camphor 10% Menthol 15%
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 thin layer using applicator adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients beeswax, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, cannabidiol, garcinia indica seed butter, olea europaea (olive) fruit oil, kaolin, lavandula angustifolia (lavender) oil, butyrospermum parkii (shea) butter, elaeis guineensis (palm) butter*, boswellia carterii (frankincense) oil, chamomilla recutita (matricaria) flower extract, carthamus tinctorius (safflower) seed oil, calendula officinalis flower extract, symphytum officinale extract, curcuma longa (turmeric) root extract, bisbolol *Responsibly sourced palm 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.Uses temporarily relieves minor aches and pains of muscles and joints associated with: simple backache strains sprains bruises Provides penetrating pain relief
Purpose
Information about the drug product’s indications for use.Purpose Camphor 10%..................Topical Analgesic Menthol 15%....................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.PlusCBD Sport Recovery Stick 1oz Camphor, Menthol COCONUT OIL SHEA BUTTER CHAMOMILE TURMERIC SYMPHYTUM OFFICINALE WHOLE CAMPHOR (NATURAL) CAMPHOR (NATURAL) YELLOW WAX JOJOBA OIL OLIVE OIL LAVENDER OIL MENTHOL MENTHOL SUNFLOWER OIL CANNABIDIOL GARCINIA INDICA SEED BUTTER FRANKINCENSE OIL SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS KAOLIN ELAEIS GUINEENSIS FRUIT BUTTER LEVOMENOL CALENDULA OFFICINALIS FLOWER
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.+PlusCBD Pain Relief Sport Recovery Stick Temporary Pain Relief for: Strains Bruises Muscle Cramps Camphor 10% Menthol 15% Pain Relieving Balm Net wt. 1 oz (28.4) 1
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on irritated skin on wounds or damaged skin
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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 855-758-7223
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 a doctor if you experience swelling or blistering of the skin condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed avoid contact with the eyes and mucous membranes do not bandage tightly or use with a heating pad
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in cool dry place, away from direct sunlight
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 irritated skin on wounds or damaged skin When using this product use only as directed avoid contact with the eyes and mucous membranes do not bandage tightly or use with a heating pad Stop use and ask a doctor if you experience swelling or blistering of the skin condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
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