Label: RANDEX HEMP CREAM 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 April 27, 2021

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  • Active Ingredient(s)

    MSM 11% ............................................................. Cooling Pain Relief
    Arnica montana 4.5% ...................................................... Treat Arthritis
    Menthol 3.6% ............................................................ Relieves muscle

  • Purpose

    Active Ingredients Purpose
    MSM 11% ............................................................. Cooling Pain Relief
    Arnica montana 4.5% ...................................................... Treat Arthritis
    Menthol 3.6% ............................................................ Relieves muscle

  • Use

    Flammab Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

  • Warnings

    For external use only.

    Flammab Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

    If pregnant or breast-feeding: Ask a health professional before use.

    Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Do not use

    ● Do not use with other ointments, creams, sprays or liniments
    ●Do not use with heating pad or device.

  • WHEN USING

    When using this product:
    ● Avoid contact with the eyes or mucous membranes
    ● Do not apply to wounds or damaged skin
    ● Do not use with other ointments, creams, sprays or liniments
    ● Do not apply to irritated skin or if excessive irritation develops
    ● Do not bandage
    ● Wash hands after use with cool water
    ● Do not use with heating pad or device.

  • STOP USE

    Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

    If pregnant or breast-feeding: Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older:
    ● apply generously to affected area
    ● massage into painful area until thoroughly absorbed into skin
    ● repeat as necessary ,but no more than 4 times daily .
    Children 12 years or younger: Consult physician.

  • Other information

    Store at room temperature with the cap closed
    Notice: because this product contains natural nutrients,color may vary.

  • Inactive ingredients

    Argan oil, Jojoba oil, Emu oil, Hempseed oil, Turmeric, Aloe vera, Squalane , Beeswax, Rosmarinus Officinalis leaf oil, Benzyl alcohol, Capsaicin, Carbomer940, Purified Water.

  • Package Label - Principal Display Panel

    81852-001-01 30000mg in 1 box

    81852-001-01 30000mg in 1 box

    81852-001 Directions 1

    81852-001 Directions 1

    81852-001 Directions 2

    81852-001 label

    81852-001 label

  • INGREDIENTS AND APPEARANCE
    RANDEX HEMP CREAM 
    randex hemp cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81852-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER4.5 mg  in 100 mg
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE11 mg  in 100 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL3.6 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    TURMERIC (UNII: 856YO1Z64F)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EMU OIL (UNII: 344821WD61)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81852-001-0130000 mg in 1 BOX; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2020
    Labeler - Randex Trading Inc. (117947972)
    Establishment
    NameAddressID/FEIBusiness Operations
    Randex Trading Inc.117947972manufacture(81852-001)
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