Label: COATS ALOE ANALGESIC- methyl salicylate lotion

  • NDC Code(s): 70211-704-08, 70211-704-33
  • Packager: TYCHASIS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 8, 2023

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  • Active Ingredient:

    Methyl Salicylate 10%

  • 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:

    Toll free number 888-650-0040

  • Package Label COATS ALOE LINIMENT

    COATS ALOE LINIMENT 8 OZ

  • INGREDIENTS AND APPEARANCE
    COATS ALOE ANALGESIC 
    methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL (UNII: L7T10EIP3A)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Colorwhite (can be off white due to natural variations of aloe vera) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70211-704-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
    2NDC:70211-704-33976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01711/02/2015
    Labeler - TYCHASIS CORPORATION (022731149)
    Registrant - TYCHASIS CORPORATION (022731149)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOMED LABORATORIES055329696manufacture(70211-704)
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