Label: CLEAN REMEDIES CR PAIN RELIEF- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • DRUG FACTS:

  • Active Ingredient:

    Menthol 2.00%

    Topical Analgesic

  • Indications:

    For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

  • Warnings:

    For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    If swallowed, consult physician.

    Do not apply

    to wounds or damaged skin. Do not  bandage tightly. 

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physician.
  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bromelain, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Full Spectrum) Hemp Extract, Carthamus Tinctorius (Safflower) Oil, Cetearyl Alcohol, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Oil, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Melia Azadirachta (Neem) Oil, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM) Papain, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Salix Nigra (Willow) Bark Extract, SD-Alcohol 40B, Stearic Acid, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Caramel Color. *Denotes cerified organic ingredient.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    CLEAN REMEDIES CR PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73371-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BROMELAINS (UNII: U182GP2CF3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PAPAIN (UNII: A236A06Y32)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCOA (UNII: D9108TZ9KG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73371-048-0385 g in 1 TUBE; Type 0: Not a Combination Product09/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/10/2019
    Labeler - Clean Remedies, LLC (035818071)
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