Label: PROPLEX GREASELESS MUSCLE RUB- menthol, unspecified form and methyl salicylate 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 January 12, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 10%
    Methyl salicylate 15%

  • Purposes

    Topical Analgesic
    Topical Analgesic

  • Use

    Temporarily relieves minor aches and pains of muscles and joints

  • Warnings

    For external use only.

    Avoid contact with eyes and mucus membranes.

    Not for prolonged use.

    Do not use

    • than otherwise directed
    • on wounds or damaged skin
    • a bandage tightly

    Stop use and ask a physician if

    • rash or excessive irritation of the skin develops
    • condition worsens or symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    Adults and children 2 years of age and older:

    • apply to affected area 3 to 4 times daily

    Children under 2 years of age:

    • consult a physician
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • close cap tightly after use
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    carbomer, cetyl alcohol, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, potassium cetyl phosphate, propylparaben, purified water, stearic acid, stearyl alcohol, triethanolamine

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    NDC # 67234-043-01

    greaseless

    muscle
    rub

    menthol 10%
    methyl salicylate 15%

    • Temporarily relieves minor aches
      and pains associated with:
      -
      simple backache
      -
      arthritis
      -
      muscle strains
      -
      bruises

    NET WT. 3 oz (85 g)

    PRO PLEX

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PROPLEX GREASELESS MUSCLE RUB 
    menthol, unspecified form and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM (UNII: RWP5GA015D)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-043-011 in 1 CARTON03/18/2019
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/18/2019
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-043)
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