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| Product NDC Code | 66902-114 | ||||
|---|---|---|---|---|---|
| Drug Name | Cold leaf nutrition muscle and joint pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1192745 | ||||
| Application Number | part348 | ||||
| Labeler Name | NATURAL ESSENTIALS, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS NATURAL Menthol USP 3.7%
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 and older Apply and gently massage painful joints and/or muscles. Repeat as needed no more than 4 times a day. Wash hands after each use with cold water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: †Aloe Barbadensis Leaf Extract, †Arnica Montana Extract, Camphor, Carbomer, Ethylhexylglycerin, †llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water. †This symbol before the ingredient indicates certified organic:
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 and 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.COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF MENTHOL MENTHOL MENTHOL ALOE VERA LEAF ARNICA MONTANA CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL PHENOXYETHANOL TEA TREE OIL .ALPHA.-TOCOPHEROL ACETATE 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 - Cold Leaf Nutrition Container Label MUSCLE & JOINT PAIN RELIEF* Leaf Cold Nutrition ALOE AND ARNICA, VITAMIN E AND TEA TREE OIL GREASELESS • VANISHING SCENT • ROLL ON FORMULA NO PARABENS • NO SYNTHETIC FRAGRANCE • NO SULFATES NO PARAFFINS • NO DEA • NO PETROLATUM • NO MINERAL OIL • NO ANIMAL TESTING 89 mL (3 fl oz) Principal Display Panel - Cold Leaf Nutrition Container 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 with other topical products Do not use with heating devices Do not use on open wounds, damaged or irritated skin Keep away from excessive heat or open flame.
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 THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN. Accidental ingestion: Seek professional help and contact Poison Control immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER: Store in cool dry area - close cap tight
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy - Breast Feeding Warning: If pregnant or breast feeding, ask a physician 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: Use only as directed. For external use only If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Avoid contact with eyes or mucous membranes Pregnancy - Breast Feeding Warning: If pregnant or breast feeding, ask a physician before use. Do not use with other topical products Do not use with heating devices Do not use on open wounds, damaged or irritated skin Keep away from excessive heat or open flame. KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN. Accidental ingestion: Seek professional help and contact Poison Control immediately.
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