Label: CHAKRA AROMA RELAXING COLOR- capsicum oleoresin patch

  • 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 19, 2019

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  • Active ingredients

    CAPSICUM OLEORESIN

  • Inactive ingredients

    Styrene isoprene rubber, silver powder, 1,2-hexandiol, 2hydroxy benzoic acid, glycerin, hydrogenated hydrocabon resin, aroma oil (patchouli oil, orange oil, lemon oil, eucalyptus oil, ylang-ylang oil, lavender oil, olibanum oil)

  • Purposes

    Topical analgesic

  • Warnings

    - It is normal that the product heats the attached area, but if a rash appears on the skin, stop using the product immediately and go to see a doctor.

    - Those who have sensitive skin or dermatitis should avoid long-hour usage(over 5 hours).

    - Be careful using the product before or after sauna and hot massage when your skin may be more sensitive than the usual.

    - If you feel itchy, remove the patch immediately and wash off the area with cold water.

    - Do NOT use the product during pregnancy.

    - Do NOT use the product to infants/children under 30 months.

    - This product is NOT a medicine, but one of the manufactured goods

  • DOSAGE & ADMINISTRATION

    For external use only

  • INDICATIONS & USAGE

    1

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Package label

    1

  • INGREDIENTS AND APPEARANCE
    CHAKRA AROMA RELAXING COLOR 
    capsicum oleoresin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72880-0100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.2 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SILVER (UNII: 3M4G523W1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72880-0100-17 in 1 PACKAGE01/01/2019
    136 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2019
    Labeler - mooni studio (694861053)
    Establishment
    NameAddressID/FEIBusiness Operations
    mooni studio694861053label(72880-0100) , manufacture(72880-0100) , pack(72880-0100)
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