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| Product NDC Code | 70211-704 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Coats aloe analgesic |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| RxCUI drug identifier | 198752 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | TYCHASIS CORPORATION | ||||||
| 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: Methyl Salicylate 10%
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 of age and older: Apply to affected areas no more than 3-4 times daily. Children under 12 years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: aloe barbadenesis leaf juice, butylene glycol, caprylyl glycol, carbomer, cetearyl alcohol, cetyl alcohol, coconut oil, disodium EDTA, eucalyptus leaf oil, glyceryl stearate, isododecane, isopentylidiol, menthol, pentylene glycol, petrolatum, phenoxyethanol, potassium palmitol hydrolyzed wheat protein, apricot kernel oil, sodium hydroxide, 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.Indications and Usage: Temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backaches strains sprains bruises
Purpose
Information about the drug product’s indications for use.Purpose: Topical analgesic, topical pain relief for intact skin.
Spl product data elements
Usually a list of ingredients in a drug product.COATS ALOE ANALGESIC METHYL SALICYLATE METHYL SALICYLATE SALICYLIC ACID ALOE VERA LEAF PETROLATUM BUTYLENE GLYCOL PENTYLENE GLYCOL COCONUT OIL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) GLYCERYL STEARATE SE CETYL ALCOHOL EUCALYPTUS OIL MENTHOL APRICOT KERNEL OIL CAPRYLYL GLYCOL PHENOXYETHANOL ISOPENTYLDIOL WATER SODIUM HYDROXIDE can be off white due to natural variations of aloe vera
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.Package Label COATS ALOE LINIMENT COATS ALOE LINIMENT 8 OZ
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: Do not use in combination with other topical analgesic products.
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: Keep out of reach of children. If accidentally ingested, seek medical help or contact poison control immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions: Toll free number 888-650-0040
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 if: Stop use and ask a doctor if condition worsens, if symptoms persist more than 7 days, or if symptoms worsen within a few days.
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnant or breastfeeding: Not recommended if you are pregnant or breastfeeding. Consult your physician.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store between 15 o C and 30 o C (59 o F and 86 o F).
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 or mucous membranes. Do not apply to wounds or damaged skin with a heating pad. Discontinue if irritation develops. Wash hands with soap and water after use. Do not banadage tightly.
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