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| Product NDC Code | 72937-180 | ||||||||||||||||
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| Drug Name | Heating pain relief |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | CREAM | ||||||||||||||||
| Application Number | part348 | ||||||||||||||||
| Labeler Name | SUNSET NOVELTIES, 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.Menthol 10% Methyl Salicylate 18%
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 over 12 years • Apply a small amount on the affected area.• Massage in circular motion, let set for a few seconds •Repeat as necessary, but no more than 3 to 4 times daily. • Wash hands with soap and water after use. Children under 12 years of age consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD&C Yellow No.6 (CI 15985).
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 Aid for temporary local relief of minor pain in muscles or joints.
Purpose
Information about the drug product’s indications for use.Topical Analgesic.
Spl product data elements
Usually a list of ingredients in a drug product.HEATING PAIN RELIEF METHYL SALICYLATE, MENTHOL GLYCERYL MONOSTEARATE CETYL ALCOHOL GLYCERETH-26 TRIDECETH-6 CAPRYLYL GLYCOL PHENOXYETHANOL COMFREY LEAF CANNABIDIOL MENTHOL MENTHOL WATER HYALURONATE SODIUM AMINO ACIDS, WHEAT PANTHENOL HYDROXYPROLINE HEXYLENE GLYCOL STEARIC ACID DIMETHICONE 1000 STEARYL ALCOHOL TROLAMINE SODIUM PYRROLIDONE CARBOXYLATE MINERAL OIL FD&C YELLOW NO. 6 METHYL SALICYLATE SALICYLIC ACID
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.SUNSET - HEATING PAIN RELIEF CREAM 2 oz sunset heating 2
SUNSET - HEATING PAIN RELIEF CREAM 4 oz sunset heating 4
SUNSET - HEATING PAIN RELIEF CREAM 8 oz sunset heating 8
SUNSET - HEATING PAIN RELIEF CREAM 16 oz sunset heating 16
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.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.Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
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: Condition worsens Redness is present Irritation develops Symptoms persist for more than 7 days or clear up occur again within a few days You experience signs injury, such as pain, swelling or blistering where the product was applied.
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.Use only as directed Do not bandage tightly or use with a heating pad Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged, broken or irritated skin If you experience an allergic reaction, discontinue use and consult a doctor. Do not expose the area treated with product to heat or direct sunlight.
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.For external use only.• Ask a doctor before use if you have redness over affected area.
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