Label: GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH BACK- menthol patch

  • NDC Code(s): 69771-012-05
  • Packager: Geri-Gentle Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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

View All Sections
  • Drug Facts

  • Active ingredient

    Menthol 5%

    Purpose

    Topical anesthetic

  • Use

    • Temporarily relieves minor aches and pains of muscles and joints due to
    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises.
  • Warnings:

    For external use only

    Do not use

    • on wounds or damaged skin
    • with heating pad
    • if you are allergic to any ingredient of this product.

    When using this product

    • use only as directed
    • avoid contact with eyes and mucous membranes or rashes

    Stop use and ask a doctor if

    • conditions worsen
    • excessive redness or irritation is present
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days.

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Adults and children 12 years of age and over:Clean and dry affected area.

    Children under 12 years of age: consult a physician.

    • clean and dry affected area
    • remove film from patch and apply to skin
    • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
    • wear each patch up to 8 hours maximum.
  • Other information:

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive ingredients:

    Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.

  • Package Labeling:

    Outer Package3Inner Package3Label03

  • INGREDIENTS AND APPEARANCE
    GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH BACK 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-012-055 in 1 POUCH07/16/2022
    10.0308 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/16/2022
    Labeler - Geri-Gentle Corporation (080367686)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!