Label: FLEX24 PAIN- camphor menthol cream

  • 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 22, 2019

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  • Active Ingredients

    Menthol, 10%
    Camphor, 3%

  • Purpose

    Topical analgesic

  • Uses

    For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains.

  • Warnings

    For external use only

    Do not

    • Apply to open wounds, or damaged, broken, or irritated skin

    Stop use and ask a doctor if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Caution

    • Discontinue use if excessive irritation of the skin develops
    • Avoid contact with the eyes and mucous membranes
    • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age or older: Apply to affected area as and when required.
    • Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) to affected area and spread smoothly over the skin with fingers.
    • Wash fingers that applied cream with water. Do not rub eyes with fingers until washed with water.
    • Children under 2 years old: consult a doctor

  • Inactive Ingredients

    Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

  • Other Information

    Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

  • Questions/Comments?

    www.FLEX24.com/paincream

  • SPL UNCLASSIFIED SECTION

    Larasan Pharmaceutical Corp.

    1287 E. Newport Center Drive, Suite 206

    Deerfield Beach, FL 33442

    Made in USA

    54641-008-01

  • PRINCIPAL DISPLAY PANEL

    Pain Cream

    Pain Relief

    • Long Lasting
    • Invisible
    • No smell

    3.4 oz (96 g)

    • Fast and Long-Lasting Pain Relief
    • Smooth, Non-Sticky, Pleasant Smell
    • Invsible Relief for Hours

    Flex24(r)

    Recover Naturally

    20190218 54641_008_01

  • INGREDIENTS AND APPEARANCE
    FLEX24 PAIN 
    camphor menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54641-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3   in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    GLUCAN ENDO-1,3-.ALPHA.-GLUCOSIDASE AGN1 (UNII: 808D59AO7C)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LACTIC ACID, L- (UNII: F9S9FFU82N)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    VITAMIN A (UNII: 81G40H8B0T)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    ALCOHOL (UNII: 3K9958V90M)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54641-008-0196 g in 1 CONTAINER; Type 0: Not a Combination Product02/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/22/2019
    Labeler - Larasan Pharmaceutical Corporation (078350375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong E E Hua Medical Technology Co., Ltd.527813247manufacture(54641-008)
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