Active Ingredient:
Methyl Salicylate 10%
Coats Aloe Analgesic
FDA Label NDC 70211-704
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tychasis Corporation for the product Coats Aloe Analgesic (NDC 70211-704). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, purpose:, warnings:, stop use if:, pregnant or breastfeeding:, indications and usage:, do not use:, keep out of reach of children:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Topical analgesic, topical pain relief for intact skin.
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.
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.
Pregnant Or Breastfeeding:
Not recommended if you are pregnant or breastfeeding.
Consult your physician.
Indications And Usage:
Temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- simple backaches
- strains
- sprains
- bruises
Do Not Use:
Do not use in combination with other topical analgesic products.
Keep Out Of Reach Of Children:
Keep out of reach of children.
If accidentally ingested, seek medical help or contact poison control immediately.
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.
Other Information:
Store between 15 o C and 30 o C (59 o F and 86 o F).
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
Questions:
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