ULTRACIN M (MENTHOL) GEL [CAL PHARMA]

  • Home
  • ULTRACIN M (MENTHOL) GEL [CAL PHARMA]

ULTRACIN M (MENTHOL) GEL [CAL PHARMA]
PDF | XML
NDC 55628-9107-4
Set ID 06f84b11-579b-4c9c-a5ad-e3f3a59b98c7
Category HUMAN OTC DRUG LABEL
Packager Cal Pharma
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • ACTIVE INGREDIENT

    MENTHOL (5%)

  • PURPOSE

    TOPICAL ANALGESIC

  • INDICATIONS & USAGE

    USE

    - TEMPORARILY RELIEVES MILD ACHES, PAINS AND INFLAMMATION OF MUSCLE AND JOINTS ASSOCIATED WITH NERVE DAMAGE AND SPORT INJURIES.

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

    DO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANE

    STOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • PREGNANCY OR BREAST FEEDING

    IF PREGNNT OR BREAST-FEEDING, ASK A HEALTHCARE PROFESSIONAL BEFORE USE.

  • DIRECTIONS

    ADULTS AND CHILDREN OVER 12 YEARS: APPLY TO AFFECTED AREA AND GENTLY MASSAGE OVER AREA UNTIL ABSORBED. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER GEL IS APPLIED.

  • INACTIVE INGREDIENTS

    Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, Boswelia Serrata Extract, Citrus Limon, Denatured Dehydrated Alcohol 40B, Gaultheria Procumbens (Wintergreen) Leaf Oil Extract, Petasites Japonicus Root (Butterbur) Extract,Pine (Pinetree) Bark Extract, Salix Nigra (Willow) Bark Extract, Zanthoxylum Americanum (Prickly Ash) Bark Extract Zanthoxylum Bungeanum Fruit (Sichuan Peppercorn) Extract, Water

  • QUESTIONS

    QUESTIONS OR COMMENTS? 1-888-551-7778

  • PRINCIPAL DISPLAY PANEL

    Ultracin M copy

  • INGREDIENTS AND APPEARANCE
    ULTRACIN M 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    CITRUS LIMON WHOLE (UNII: EEI224A33Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    WILLOW BARK (UNII: S883J9JDYX)  
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
    ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55628-9107-4120 mL in 1 TUBE; Type 0: Not a Combination Product01/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/24/2016
    Labeler - Cal Pharma (078721283)
    Registrant - Cal Pharma (078721283)
View All Sections

Related Drugs

Search DailyMed Drugs