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 January 26, 2022

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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, 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

    conditions worsens or if symptoms persist for more than 7 days

  • Caution

    • Discontinue use if there is redness or excessive irritation on skin
    • Avoid contact with eyes
    • Arthritis: If pain persists 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

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

  • Directions

    • Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily
    • Children under 2 years old: consult a doctor
    • Tear and apply in a circle of 25 mm diameter 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
  • 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 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

  • PRINCIPAL DISPLAY PANEL

    FLEX24

    RECOVER NATURALLY

    PAIN CREAM

    SAMPLE PACK

    NET wt. 0.14 oz (3.8g)

    Dist: FLEX24, INC.

    4020 GALT OCEAN DRIVE, STE. 1607

    FORT LAUDERDALE, FL 33308

    CALL TOLL FREE 844.4.FLEX24

    NDC 73218-001-01

    20190927 Flex24Inc_Pain_Cream

  • INGREDIENTS AND APPEARANCE
    FLEX24 PAIN 
    camphor, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73218-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  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 FLOWER (UNII: OZ0E5Y15PZ)  
    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 (UNII: G0R4UBI2ZZ)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)  
    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, D- (UNII: A7E6112E4N)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73218-001-013.8 g in 1 PACKET; Type 0: Not a Combination Product09/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/29/2019
    Labeler - Flex24, Inc. (117114024)
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