Label: MMM ICE GEL- menthol gel

  • NDC Code(s): 69822-013-80
  • Packager: Southern Sales & Services, Inc
  • 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 1, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredients Menthol 2.0% Purpose: Topical Analgesic

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

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

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • WARNINGS

    For external use only. Avoid contact with eyes.

  • WHEN USING

    • do not bandage tightly
    • do not apply to wounds or damaged skin

  • STOP USE

    Stop use and ask a doctor if

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • STORAGE AND HANDLING

    Other information

    • do not freeze
    • Keep lid tightly closed

  • INACTIVE INGREDIENT

    Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanol- amine, FD&C Blue no. 1, purified water.

  • PRINCIPAL DISPLAY PANEL

    227 g NDC: 69822-013-80

    MMM Therapeutic Ice Gel

    Topical Analgesic

    Net Wt. 8 oz

    MMM Ice Gel

  • INGREDIENTS AND APPEARANCE
    MMM ICE GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-013-80227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2021
    Labeler - Southern Sales & Services, Inc (013114906)
    Registrant - Southern Sales & Services, Inc (013114906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Sales & Services, Inc013114906label(69822-013)