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Product NDC Code | 73616-210 | ||||||||
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Drug Name | Hemp pain |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | part348 | ||||||||
Labeler Name | Sacred Enterprises, LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Menthol 2% Topical Analgesic Methyl Salicylate 6% Topical Analgesic
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Menthol 2% | Topical Analgesic |
Methyl Salicylate 6% | Topical Analgesic |
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 12 and older Generously apply 2-3 times daily or more often if needed on and around the affected area. Massage in until absorbed, reapply before bedtime and in the morning. Use before and after sports work outs and competitions. Children under 12 years of age Ask a doctor.
| Adults and children 12 and older | Generously apply 2-3 times daily or more often if needed on and around the affected area. Massage in until absorbed, reapply before bedtime and in the morning. Use before and after sports work outs and competitions. |
Children under 12 years of age | Ask a doctor. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzoic acid, Butyrospermum parkii ( shea) butter, Cannabis sativa seed oil, Ceteareth-20,cetearyl alcohol, Cetyl alcohol, Cocos Nucifera ( coconut) oil, Ethylhexylglycerin, Glycereth 2 cocoate, Glyceryl stearate SE, Helianthus annuus ( sunflower) seed oil , PEG -150 stearate, PEG-20 hydrogenated lanolin, PEG-40 stearate, Phenoxyethanol polyacrulate-13, Polyisobutene, Polysorbate 20, Polysorbate 60, Theobroma cacao ( cocoa) seed butter, Water.
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 For the temporary relief of minor aches and pains for muscles and joints associated with : Simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Active Ingredient Purpose Menthol 2% Topical Analgesic Methyl Salicylate 6% Topical Analgesic
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Menthol 2% | Topical Analgesic |
Methyl Salicylate 6% | Topical Analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.Hemp Pain MENTHOL, UNSPECIFIED FORM and Methyl Salicylate MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Methyl Salicylate SALICYLIC ACID SHEA BUTTER Benzoic Acid Cannabis Sativa Seed Oil POLYOXYL 20 CETOSTEARYL ETHER Cetyl Alcohol COCONUT OIL ETHYLHEXYLGLYCERIN GLYCERETH-20 COCOATE Glyceryl Stearate SE SUNFLOWER OIL Peg-20 Hydrogenated Lanolin Peg-40 Stearate PEG-150 STEARATE Phenoxyethanol POLYACRYLAMIDE (1300000 MW) POLYISOBUTYLENE (1000 MW) Polysorbate 20 Polysorbate 60 COCOA BUTTER CETOSTEARYL ALCOHOL water
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.PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label SACRED ® revive rejuvenate heal infused pain lotion PRINCIPAL DISPLAY PANEL - 59 ml Bottle Label
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 for Sacred Hemp Pain Lotion
Distributed by SACRED ® 1916 Raymond Drive, Northbrook, IL 60062
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.For external use only Do not use if seal is missing or broken otherwise than as directed
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 and pets. 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 [email protected]
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 pain persists for more than 3 days condition worsens New symptoms occur if redness irritation or swelling are present
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use
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 if seal is missing or broken otherwise than as directed Stop use and ask a doctor if pain persists for more than 3 days condition worsens New symptoms occur if redness irritation or swelling are present If pregnant or breast-feeding , ask a health professional before use Keep out of reach of children and pets. 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