Label: RELIEVE YOUR PAIN- menthol cream

  • NDC Code(s): 72683-005-01
  • Packager: Proximity Capital Partners LLC dba Asutra
  • 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 April 29, 2021

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  • Active Ingredients

    Menthol USP 10%

  • Purpose

    Menthol USP 10%.....................Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    Use only as directed. For external use only.

    When using this product:

    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments.

    Stop use and ask doctor if:

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and reoccur again within a few days

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

  • Directions

    Adults and children 2 years of age and older:

    • Apply to affected area not more than 3 to 4 times daily.
  • Other Information

    • Store in a cool, dry place.
    • Avoid direct sunlight.
    • Tamper-evident for your protection. Use only if safety seal is intact.
    • Keep away from excessive heat or flame.
  • Inactive Ingredients

    Aqua, Magnesium Chloride, Dimethyl Sulfone (Methylsulfonylmethane), Glyceryl Stearate SE, Cetearyl Alcohol, Sweet Almond Oil (Prunus Amygdalus Dulcis), Shea Butter (Butyrospermum Parkii), Ceteareth-20, Glycerin, Pentylene Glycol, Undecane, Tocopheryl Acetate, Cetyl Palmitate, Arnica Montana Flower Extract, Tocopherol, Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone

  • Questions or Comments?

    888-819-6472; Monday-Friday, 9am-5pm CT

    Report any serious side effects to number above.

  • PRINCIPAL DISPLAY PANEL

    NDC 72683-005-01

    Non-toxic

    Paraben Free

    Asutra*

    Relieve

    your

    pain

    10% Menthol

    Pain Relief Cream

    With Moisturizing

    Magnesium and

    Arnica Montana

    Net Wt. 3.4 oz. | 96 g.

    1

    2

  • INGREDIENTS AND APPEARANCE
    RELIEVE YOUR PAIN 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TRIDECANE (UNII: A3LZF0L939)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    UNDECANE (UNII: JV0QT00NUE)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72683-005-0196 g in 1 TUBE; Type 0: Not a Combination Product04/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/29/2021
    Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLITEINT Ko zmetikum gyarto es fo rgalmazo termelo es kereskedelmi Ko rlato lt Felelo ssegu Tarsasag401476254manufacture(72683-005)
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