CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB (MENTHOL, CAMPHOR, CAPSAICIN) GEL [CAJUN THERAPEUTICS, LLC]

CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB (MENTHOL, CAMPHOR, CAPSAICIN) GEL [CAJUN THERAPEUTICS, LLC]
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NDC 70904-756-01
Set ID f418e0db-6baf-48fb-a023-1d1bf3a1b848
Category HUMAN OTC DRUG LABEL
Packager Cajun Therapeutics, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol 9.00%; Camphor 3.00%, Capsaicin 0.025%

    Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of the muscles and joints

  • Warning

    For external use only. Do not apply to wounds or damaged or irritated skin. Avoid contact with eyes and mucous membranes. If this occurs, wash the area thoroughly with water.

    • You may experience a burning sensation when using this product which is normal and related to the way the product works. With regular use this sensation will disappear after several days.
    • Do not apply immediately before or after activities such as strenuous exercise, bathing, swimming or sun bathing
    • Do not tightly wrap or bandage the treated areas
    • Do not apply heat or heating pad to the treated areas immediately before or after use

    Stop use and ask a doctor if

    • Symptoms persist for more than seven days, discontinue use and consult a physician
    • Rash/blistering occurs
    • Difficulty breathing or swallowing occurs
    • Severe burning pain persists

    Keep out the reach of children.

    If swallowed, get medical help or contact a poison control center immediately. If pregnant or breastfeeding, ask a physician before use.

  • Directions

    • Apply to affected area and gently massage until cream is thoroughly absorbed
    • Repeat up to three to four times daily
    • Unless treating hands, wash hands thoroughly with soap and water immediately after use
    • For persons under 18 years old, consult a physician before using
  • Other information:

    This product may cause allergic reactions in some individuals. Test on a small area before use. Stop use and ask a doctor if blisters develop.

  • Inactive Ingredients:

    Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Cetyl Alcohol, Capsaicin, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Methylsulfonylmethane, Phenoxyethanol, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine, Parfum (Fragrance).

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB 
    menthol, camphor, capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70904-756
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)30 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL90 mg  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70904-756-01113 g in 1 TUBE; Type 0: Not a Combination Product08/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/12/2016
    Labeler - Cajun Therapeutics, LLC (079835064)

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