ULTRACIN M (MENTHOL) GEL [CAL PHARMA]

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ULTRACIN M (MENTHOL) GEL [CAL PHARMA]
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NDC 55628-9051-4
Set ID 4ff54f99-5eec-4209-932e-3ad076309c52
Category HUMAN OTC DRUG LABEL
Packager Cal Pharma
Generic Name
Product Class
Product Number
Application Number PART348
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  • ACTIVE INGREDIENT

    MENTHOL (10%)

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    Temporarily relieves mild aches, pains, and in.ammation of muscle and joints associated with nerve damage and sport injuries.

  • PREGNANCY OR BREAST FEEDING

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

  • WARNINGS

    For external use only. Do not use on open wounds, cuts, damaged or infected skin as well as in the eye, mouth, genitals or any other mucous membrane. Stop use and consult your physican 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.

  • DIRECTIONS

    Adults and children over 12 years: Apply to a.ected area and gently massage over area until absorbed. Do not use more than 4 timesa 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 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:55628-9051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 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)  
    LIME (CITRUS) (UNII: 8CZS546954)  
    ALCOHOL (UNII: 3K9958V90M)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
    ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55628-9051-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/29/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/29/2012
    Labeler - Cal Pharma (078721283)
    Registrant - Cal Pharma (078721283)
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