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| Product NDC Code | 82551-119 | ||||
|---|---|---|---|---|---|
| Drug Name | Cooling |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 2045038 | ||||
| Application Number | M017 | ||||
| Labeler Name | FULL EIGHT Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT MENTHOL 1.2%
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 18 years of age and older: Massage into skin at affected areas before bed & when symptoms arise
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Purified water, Glycerin, SD Alcohol, Carbomer, Olive Oil, Tetrasodium EDTA, Spearmint Oil, Lemongrass oil, Eucalyptus Oil, Peppermint Oil, Camphor, Triethanolamine, F D & C Blue #1, DMDM Hydantoin
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.USE Temporary relief from minor aches and pain such as cramps, sore muscles, arthritis, muscle strains, and bruises
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.COOLING MENTHOL CAMPHOR OIL TROLAMINE FD&C BLUE NO. 1 DMDM HYDANTOIN WATER ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE OLIVE OIL EDETATE SODIUM TETRAHYDRATE GLYCERIN SPEARMINT OIL EAST INDIAN LEMONGRASS OIL EUCALYPTUS OIL PEPPERMINT OIL 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.LBL COOLING GEL
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.
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? 704-461-3009 • [email protected]
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 and open flame Ask a doctor before use if you have: Sensitive skin When using this product: Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays, or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breast-feeding: Ask a doctor before use
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