Label: FORMULA45 ARTHRITIS BLEND- methyl salicylate, menthol, unspecified form cream

  • NDC Code(s): 70169-701-01
  • Packager: Shift Consulting Group, 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 February 7, 2017

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

  • Drug Facts:
  • Active Ingredient:

    Methyl Salicylate 20.00%

    Menthol 10.00%

    Purpose:

    Topical Analgesic

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  • Indications:

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • and sprains
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  • 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.

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  • 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.
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  • 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.

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    FORMULA45 ARTHRITIS BLEND 
    methyl salicylate, menthol, unspecified form cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70169-701
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 200 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70169-701-01 1 in 1 CARTON 02/07/2017
    1 113 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/16/2015
    Labeler - Shift Consulting Group, Inc. (079991681)
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