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| Product NDC Code | 0363-0355 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Overnight cold therapy pain relief |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Walgreen Co. | ||||||
| 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 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 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician wash hands after use with cool water
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 Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, 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 Temporarily relieves 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.Overnight Cold Therapy Pain Relief Menthol, unspecified form MENTHOL, UNSPECIFIED FORM 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) GLYCERIN ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE ILEX PARAGUARIENSIS LEAF SILICON DIOXIDE .ALPHA.-TOCOPHEROL TROLAMINE 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 – 74 mL Bottle Label Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredient in Biofreeze ® Roll-On †† OVERNIGHT Cold Therapy Pain Relief MENTHOL 4%/TOPICAL ANALGESIC Roll On No Mess For arthritis, back pain, sore muscles & joints Soothing menthol Paraben free Lavender scent 2.5 FL OZ (74 mL) Principal Display Panel – 74 mL Bottle Label
Principal Display Panel – 89 mL Tube Label Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredient in Biofreeze ® Overnight Gel †† OVERNIGHT Cold Therapy Pain Relief Gel MENTHOL 4%/TOPICAL ANALGESIC For arthritis, back pain, sore muscles & joints Soothing menthol Paraben free Lavender scent 3 FL OZ (89 mL) Principal Display Panel – 89 mL Tube 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 . 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 at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight
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 pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
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 or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device
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 excessive heat or open flame. When using this product use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age 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