Label: RUGBY MENTHOL HOT COLD PATCH- menthol patch

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

Drug Label Information

Updated March 25, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

  • Purpose

    Topical analgesic

  • Warnings

    For external use only

  • When using this product

    ■ use only as directed

    ■ Rare cases of serious burns have been reported with products of this type

    ■ don't bandage tightly or use with a heating pad

    ■ Avoid contact with the eyes and mucous membranes

    ■Don't apply to wounds or damaged skin

    ■ do not use at the same time as other topical analgesics

  • Stop use and consult a doctor

    ■ condition worsens

    ■ redness is present

    ■ irritation develops

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • Keep out of reach of children

    Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

  • Directions

    Directions Adults and children 12 years of age and over:

    • carefully remove backing from patch
    • apply sticky side of patch to affected area
    • wear one patch up to 8 hours
    • repeat as necessary, but no more than 3 times daily
    • discard patch after single use
    • reseal pouch after opening.
    • Children under 12 years of age: consult a physician.
  • Other safety information

    Store at room temperature, not to exceed 86F (30C)

  • Inactive Ingredients

    CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Questions

    Call 1-800-645-2158


  • INDICATIONS & USAGE

    Targeted, long-lasting pain relief

  • Rugby Menthol Cold / Hot Patch

    label

  • INGREDIENTS AND APPEARANCE
    RUGBY MENTHOL HOT COLD PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1332-155 in 1 CARTON07/01/2021
    19 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/01/2021
    Labeler - RUGBY LABORATORIES (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(0536-1332)