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| Product NDC Code | 81683-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Rocksauce icy cold pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | part348 | ||||
| Labeler Name | Implus Footcare, LLC | ||||
| 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 Menthol6%
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: Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Aloe Barbadensis(Aloe Vera) Leaf Juice, Arctium Lappa(Burdock)Root Extract, Arnica Montana Flower Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Water, Camellia Sinensis(Green Tea) Leaf Extract, Cinnamomum Camphora Bark Oil, Ethyl Alcohol, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Maltodextrin, Triethanolamine, 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: Provides soothing cold to sore muscles and joints.
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.RockSauce ICY COLD PAIN RELIEF Menthol ILEX PARAGUARIENSIS LEAF ARCTIUM LAPPA ROOT CHAMOMILE FLOWER OIL CARBOMER 940 ALOE VERA LEAF CAMPHOR OIL ISOPROPYL MYRISTATE MALTODEXTRIN WATER MENTHOL MENTHOL GLYCERIN TROLAMINE ARNICA MONTANA FLOWER ALCOHOL GREEN TEA LEAF
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.image of bottle label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Consult a doctor and discontinue use if irritation occurs. Ask a health professional before use if pregnant or breastfeeding. Ask a doctor before using if you have sensitive skin.
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 otherwise than as directed.
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: In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.
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, do not: heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.
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. Avoid contact with eyes, mucous membrane or broken skin.
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