Label: DR JOE LAB PMS MENSTRUAL PAIN RELIEF CREAM DR JOE LAB- menstrual pain relief cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 2, 2023

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  • Active Ingredients

    Drug Facts

    Active Ingredients Purpose

    Menthol 1.4% Topical Analgesic

    Methyl Salicylate 10% Topial Analgesic

  • Uses

    Temporarily relieves minor pain associated with menstrual cramps.

  • Warnings

    For External use only

  • When using this product

    - use only as directed

    - avoid contact with eyes or mucous membranes

    - do not apply to wounds or damaged skin

  • Stop use and ask doctor if

    -Condition worsens

    - symptoms persist for more than 7 days or clean up and occur again within a few days

    - redness is present

    - irritation develops

  • Alleregy alerts

    Do not use if you are allergic to salicylates ( including asprin) without consulting a physician

  • If Pregnant or breast-feeding

    - ask a health professional before use.

  • Keep out of reach of the children

    If Swallowed , get medical help or contact a poison control center right away

  • Directions

    Adults & children over 12 years of age:

    - Apply to affected area

    - massage into painful area until thoroughly absorbed into skin

    - repeat as necessary but no more than 4 times daily.

  • Other information

    Protect the product in this container from excessive heat and direct sun. Store at 20-25 Degree Celcius( 66-77 F )

  • Inactive Ingredients

    Water, Sodium Polyacrylate, Jojoba Oil, Caprylyl Glycol, Vitamin E Acetate, Pro-Vitamin B5, Isoprpyl Myristate, Eucalyptus Leaf Oil, Camphor Leaf Oil, Hydrogenaed Polydecene, Sunflower Oil, Trideceth-6, Citric Acid, Acrylates/Palmeth-25, Phenoxyethanol, Hexylene Glycol, Acrylate Copolymer, Sorbic Acid

  • Questions or comments ?

    1-855-349-7735 or visit www.drjoelab.com to report serious adverse events associated with use of the product

  • Description

  • DOSAGE & ADMINISTRATION

    Massage into painful area until thoroughly absorbed into skin

    For External Use Only

  • INDICATIONS & USAGE

    to be used in PMS Menstrual Pain relief

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    DR JOE LAB PMS MENSTRUAL PAIN RELIEF CREAM  DR JOE LAB
    menstrual pain relief cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82557-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-1.4 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)  
    HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82557-100-01113 g in 1 TUBE; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01404/01/2022
    Labeler - DR JOE LAB Inc. (122311139)
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Safety

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