Label: ALHUA HUOGAN PAIN RELIEVING PATCH- menthol 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 5, 2013

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  • Drug Facts

    Active Ingredient

    Menthol      5%

  • Purpose

    Topical Analgesic
  • Uses

    For temporary relief of minor aches and pains of muscles and joints due to:

    • simple backache
    • sprains
    • strains
    • bruises
    • arthritis
  • Warnings

    For external use only

  • When using this product

    • Do not use otherwise than as directed
    • Avoid contact with eyes
    • Do not apply on wounds, damaged or irritated skin
    • Do not bandage tightly
    • Do not use if the property of this product changes
  • Stop use and ask a doctor if

    • Conditions worsen
    • Symptoms persist for more than 7 days, or symptoms clear up and occur again within a few days
    • Rash, itching, or excessive skin irritation develops
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    Adults and children 12 years of age and over: 

    • Clean and dry affected area
    • Open pouch and remove patch
    • Peel off protective backing and apply sticky side to affected area
    • Apply patch for less than 4 hours a day
    • Wash hands with soap after touching patch

    Children under 12 years of age: consult a doctor.

  • Other information

    • Avoid storing in direct sunlight
    • Protect from excessive moisture and heat
  • Inactive ingredients

    Honeysuckle Vine (Ren Dong Teng), Isatis Tinctoria (Ban Lan Gen), Paeonia Lactiflora Root (Bai Shao Root)

  • Carton Label Image

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    Carton Label Image
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  • INGREDIENTS AND APPEARANCE
    ALHUA HUOGAN PAIN RELIEVING PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53791-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol30 mg
    Inactive Ingredients
    Ingredient NameStrength
    LONICERA JAPONICA TOP (UNII: 60Q6UP226V)  
    ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53791-118-013 in 1 CARTON
    11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/05/2013
    Labeler - U.S.A. AH LLC (174588231)
    Establishment
    NameAddressID/FEIBusiness Operations
    U.S.A. AH LLC174588231label(53791-118)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZIYANG YIPING TIANXIA BIO-TECH. LLC.421276484manufacture(53791-118)
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