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Product NDC Code | 66902-920 | ||||||
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Drug Name | Cvs health pain relief |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
Application Number | M017 | ||||||
Labeler Name | NATURAL ESSENTIALS, INC. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 4%
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 years of age and over: apply to affected area using roller ball not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water Children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, 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 of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.CVS Health Pain Relief Menthol, unspecified form ALOE VERA LEAF ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GLYCERIN ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE ILEX PARAGUARIENSIS LEAF SILICON DIOXIDE .ALPHA.-TOCOPHEROL TROLAMINE WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
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 - 74 mL Bottle Label CVS Health ® Compare to the active ingredient in Biofreeze ® Pain Relief Roll-On* Pain Relief Roll-On MENTHOL 4% Fast-acting pain relief Relieves muscle pain Soothes aggravated nerves Vanishing scent 2.5 FL OZ (74 mL) Principal Display Panel - 74 mL Bottle Label
Principal Display Panel - 89 mL Tube Label CVS Health ® Compare to the active ingredient in Biofreeze ® Pain Relief Gel* Pain Relief Gel MENTHOL 4% Fast-acting pain relief Relieves muscle pain Soothes aggravated nerves Vanishing scent 3 FL OZ (89 mL) Principal Display Panel - 89 mL Tube Label
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 if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin with a heating pad or TENS device
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store in a cool place away from direct sunlight store with cap closed tightly
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 condition worsens rash, itching, redness or excessive irritation of the skin develops 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 do not bandage tightly avoid contact with eyes or mucous membranes
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 Flammable: Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin with a heating pad or TENS device When using this product Use only as directed do not bandage tightly avoid contact with eyes or mucous membranes Stop use and ask a doctor if condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, 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