EXTERNAL ANALGESIC (CAMPHOR, CAPSICUM, MENTHOL) PATCH [HMONG 21]

EXTERNAL ANALGESIC (CAMPHOR, CAPSICUM, MENTHOL) PATCH [HMONG 21]
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NDC 70927-001-00
Set ID 3b6155a5-51aa-2780-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Hmong 21
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredients

    Camphor 9.6%

    Capsaicin 0.05%

    Menthol 7.8%

  • Purpose

    External Analgesic

  • Uses

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

    -simple backache

    -arthritis

    -strains

    -bruises

    -sprains

  • Warnings

    When using this product

    -avoid contact with the eyes

    - do not apply to wounds or damaged skin

    -do not bandage tightly

    Stop use and ask a doctor if

    - condition worsens

    -if synthoms oersust for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use.

  • 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:

    -Clean and dry affected area.

    -Remove from backing film and apply.

    -Remove from the skin after at most 8 hours' application.

    -Apply to the affected area not more than 3 times daily.

    -Children under 12 years of age: Consult a doctor.

  • Inactive ingredients

    Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-ethylhexylacrylate, Glycerin, Methyl Acrylate, Polyacrylate, polyacrylic Acid, sodium polyacrylatem, Tartaric Acid, Water.

  • Label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    EXTERNAL ANALGESIC 
    camphor, capsicum, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70927-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96 mg  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.5 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL78 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    CAPSICUM (UNII: 00UK7646FG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70927-001-004 g in 1 PATCH; Type 0: Not a Combination Product08/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/25/2016
    Labeler - Hmong 21 (080352437)

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