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| Product NDC Code | 84733-302 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Pain reliever |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| RxCUI drug identifier | 1923699 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | Kool 'N Fit Inc. | ||||||||
| 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 Camphor 0.20% Menthol 1.25%
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.DIRECTION ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE. DO NOT USE, CONSULT DOCTOR.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT ALCOHOL SDA-40, AQUA DEIONIZED, USP, BERGAMOT OIL, CITRUS OIL, EUCALYPTUS OIL, JUNIPERBERRY OIL, PINE NEEDLE OIL, MYRISTICA OIL, LAVENDULA OIL, LEMON OIL, PEPPERMINT OIL, ROSEMARY OIL, THYME 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.USE USE ONLY AS DIRECTED.
Purpose
Information about the drug product’s indications for use.PURPOSE for the temporary relief of minor aches and pains of muscle and joints asscoiated with simple backache, strains, brusies and sprains.
Spl product data elements
Usually a list of ingredients in a drug product.Pain Reliever Camphor, Menthol WATER BERGAMOT OIL POLYSORBATE 20 PEPPERMINT OIL TERT-BUTYL ALCOHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) PINE NEEDLE OIL (PINUS MUGO) THYME OIL NUTMEG OIL LEMON OIL EUCALYPTUS OIL JUNIPER BERRY OIL LAVENDER OIL MENTHOL MENTHOL ROSEMARY OIL
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.PRODUCT LABEL KOOL N FIT - PAIN RELIEVING SPRAY Kool N Fit Muscle Pain Relieving spray
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.RECENT MAJOR CHANGES SECTION COMPLETE ALL CONTENT SECTIONS TO ALIGN WITH PRODUCT PACKAGING
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 CHILDREN - IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFO Store in a cool dry place
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.WARNING FOR EXTERNAL USE ONLY.
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