Label: HEIBAITONG PAIN RELIEVING PATCH- menthol, camphor 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 December 11, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Menthol       5%

    Camphor     3.5%

  • PURPOSE

    Menthol         External Analgesic

    Camphor       External Analgesic

  • USES

    For the temporary relief of minor aches and pains of muscles and joints due to: simple backache, arthritis, strains, bruises, sprains.

  • Warnings

    For External Use only.

  • Do not use

    on wounds.
    on irritated or damaged skin.
    if the appearance of this product has changed.
    in excess of 12 hours.
    if you are hypersensitive to this product.
    otherwise than as directed.

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    pregnant.
    taking other medications.

  • When using this product

    avoid contact with the eye or mucous membranes.
    do not bandage tightly.
    supervise use by children.
    use caution if prone to allergic reactions.

  • STOP USE AND ASK A DOCTOR IF

    condition worsens.
    symptoms persist for more than 7 days.
    symptoms clear up and occur again within a few days.
    excessive irritation of the skin develops.
    redness is present.
    in conditions affecting children under 12 years of age.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older: This product can be applied up to 168 hours of repeated uses. Remove the package from package. Heat up the patch until it easily gets separated and it becomes soft and glossy (avoid touching on skin when it is hot from the heat). Apply one or two patches to affected area once a day. Remove after every 6-12 hours depending on symptoms. During treatments, it is normal to feel the heat from patch itself. It can be removed anytime if discomfort occurs. Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor. Children under 2 years of age: Do not use, consult a doctor. Refer to the above warnings: use otherwise than as directed may be dangerous.

  • Other Information

    Keep container tightly closed.
    Store below 20 ℃ (68 ℉) in a dry area.

  • Inactive Ingredients

    NOTOPTERYGIUM INCISUM ROOT, ANGELICA PUBESCENS ROOT, SINOMENIUM ACUTUM STEM, PERIPLOCA SEPIUM ROOT BARK, SAPOSHNIKOVIA DIVARICATA ROOT, ATRACTYLODES LANCEA ROOT, CNIDIUM MONNIERI FRUIT, ALPINIA OFFICINARUM WHOLE, CUMINUM CYMINUM WHOLE, CINNAMON, ANGELICA SINENSIS ROOT, PAEONIA LACTIFLORA ROOT, PAPAYA, CAESALPINIA SAPPAN WOOD, RHUBARB, PINUS TABULIFORMIS BARK, DIPSACUS CHINENSIS WHOLE, LIGUSTICUM WALLICHII ROOT, ANGELICA DAHURICA ROOT, FRANKINCENSE OIL, MYRRH, BORNEOL, CLOVE OIL, CHINESE CINNAMON, CINNAMOMUM CASSIA TWIG, PANAX NOTOGINSENG ROOT, SAFFRON, ERYCIBE OBTUSIFOLIA STEM, PIPER KADSURA STEM, FOSSILIZED MAMMAL BONE

  • Questions or Comments?

    Relief Saturated LLC
    Alhambra, California 91801

    Call (626) 247-0304 or
    E-mail: kyle.hsieh18@gmail.com

  • Manufactured by Kangyou Pharmaceutical Limited Company2nd Building, 1st Floor, 8 Km Half of Ha Double Highway in Dao Li DistrictHarbin 150076, China

    Distributed by

    Relief Saturated LLC
    Alhambra, California 91801 USA

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    HEIBAITONG PAIN RELIEVING PATCH 
    menthol, camphor patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72328-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.0 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    SINOMENIUM ACUTUM STEM (UNII: BBH96IEM66)  
    PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    ALPINIA OFFICINARUM WHOLE (UNII: 6D24820XKG)  
    CUMINUM CYMINUM WHOLE (UNII: 5BD8A7OW68)  
    CINNAMON (UNII: 5S29HWU6QB)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    PAPAYA (UNII: KU94FIY6JB)  
    CAESALPINIA SAPPAN WOOD (UNII: 086263LQDD)  
    RHUBARB (UNII: G280W4MW6E)  
    PINUS TABULIFORMIS BARK (UNII: 3G75L8C3RU)  
    DIPSACUS CHINENSIS WHOLE (UNII: O6JK1ZU9NN)  
    LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    MYRRH (UNII: JC71GJ1F3L)  
    BORNEOL (UNII: M89NIB437X)  
    CLOVE OIL (UNII: 578389D6D0)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    SAFFRON (UNII: E849G4X5YJ)  
    ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI)  
    PIPER KADSURA STEM (UNII: 80IOP41EL7)  
    MAMMAL BONE, FOSSILIZED (UNII: 0N1T3913DA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72328-001-011 in 1 POUCH07/23/2018
    113 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/23/2018
    Labeler - Harbin Kangyou Pharmaceutical Limited Company (554409031)
    Registrant - Harbin Kangyou Pharmaceutical Limited Company (554409031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harbin Kangyou Pharmaceutical Limited Company554409031manufacture(72328-001)