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Pain Relieving Analgesic (Singhfam Corporation)

Available Formats

Dosage Form Package Information Links
GEL 227 g in 1 JAR (52920-123-03) Label Information

Complete Pain Relieving Analgesic Information

  • Active Ingredients

    Menthol 2%


  • Purpose

    Topical Analgesic


  • Uses

    For temporary relief of minor aches and muscles pain: simple back aches, sprains and strains common to sports activities, joint pains associated with arthritis.


  • Directions

    Clean skin of all other lotions, creams, ointments, liniments: Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times within a 24 hour period. No protective cover needed. Do not apply to children under 2 years of age.


  • Warnings

    Use only as directed.

    Keep out of reach of children.

    For external use only. If swallowed contact a physician or poison control center immediately. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free of any creams ointments, sprays or liniments. Do not cover with bandage.

    Do not use

    with heating pads or heating devices.

    Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.


  • Inactive Ingredients

    Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Mathylisothiazolinone, FD&C Blue #1.


  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL
    elizabeth style
    Therapeutic, Greaseless
    Fast, temporary relief from minor aches and pains
    Blue Ice
    Net Wt. 8 Oz (227 g)
    PAIN RELIEVING ANALGESIC GEL
    PRINCIPAL DISPLAY PANEL - 8 oz


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ANALGESIC 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52920-123
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.54 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52920-123-03 227 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 09/21/2009
    Labeler - Singhfam Corporation (019499958)
    Establishment
    Name Address ID/FEI Business Operations
    Anicare Pharmaceuticals Pvt. Ltd. 916837425 MANUFACTURE(52920-123)