Label: ACHY- menthol cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 15, 2016

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  • ACTIVE INGREDIENT

    Menthol 1.5%

  • PURPOSE

    Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

  • WARNINGS

    Warnings

    For external use only.

    Do not use other than directed

    When using this product

    • avoid contact with eyes and mucous membranes
    • do not apply tp wounds or broken skin

    Stop use and ask a doctor if

    • excessive skin irritation develops
    • condition worsens
  • DOSAGE & ADMINISTRATION

    Adults and children 3 years of age and older liberally massage to affected are not more than 4 times daily

    Children under 3 years of age ask a doctor before using

  • INACTIVE INGREDIENT

    Organic extra virgin olive oil, organic comfrey oil, organic arnica oil, beeswax, Indian lemongrass essenttial oil, French clary sage essential oil, Spanish rosemary essential oil, and Natural Vitamin E

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away (1-800-222-1222

  • INDICATIONS & USAGE

    Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.​

  • PRINCIPAL DISPLAY PANEL

    Achy

  • INGREDIENTS AND APPEARANCE
    ACHY 
    menthol cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71157-0017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL28 g  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71157-0017-190 mL in 1 CAN; Type 0: Not a Combination Product12/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/19/2016
    Labeler - Kelada Creative Group LLC DBA SALVE (014340121)
    Registrant - Kelada Creative Group LLC DBA SALVE (014340121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kelada Creative Group LLC DBA SALVE014340121manufacture(71157-0017)
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