FORMULA45 ARTHRITIS BLEND (METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM) CREAM [SHIFT CONSULTING GROUP, INC.]

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  • FORMULA45 ARTHRITIS BLEND (METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM) CREAM [SHIFT CONSULTING GROUP, INC.]

FORMULA45 ARTHRITIS BLEND (METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM) CREAM [SHIFT CONSULTING GROUP, INC.]
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NDC 70169-701-01
Set ID 29009789-6f8f-449b-a1bd-da4fad00b621
Category HUMAN OTC DRUG LABEL
Packager Shift Consulting Group, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts:

  • Active Ingredient:

    Methyl Salicylate 20.00%

    Menthol 10.00%

    Purpose:

    Topical Analgesic

  • Indications:

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • and sprains
  • Warnings:

    For external use only

    Allergy Alert: If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • children 12 years of age with arthritic conditions

    Ask a physician before use if

    you have redness over the affected area.

    When using this product

    • avoid contact with eyes and mucus membranes
    • do not bandage highly

    Stop use and ask a physician if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clearup and occur again within a few days
    • excessive skin irritation occurs.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions:

    Use only as directed

    • Adults and children over 12 years of age apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age consult a physician.
  • Other Ingredients:

    Aqua (deionized water), arnica montana (arnica) extract, blue 1, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, chondroitin sulfate, dimethyl sulfone (MSM), ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, polysorbate-20, stearic acid, yellow 5.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    FORMULA45 ARTHRITIS BLEND 
    methyl salicylate, menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70169-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70169-701-011 in 1 CARTON02/07/2017
    1113 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/16/2015
    Labeler - Shift Consulting Group, Inc. (079991681)
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