Label: AGERANIUM PATCH- capsaicin 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 29, 2017

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  • Active ingredient

    Capsacin 0.228mg

  • Purpose

    External analgesic

  • Uses

    For temporary relief of minor aches & pains of muscles & joints associated with:

    - arthritis

    - simple backace

    - strains

    - bruises

    - sprains

  • Warnings

    For external use only

    Allergy alert: If prone to have an allergic reaction to Capsaicin, cunsult a doctor before use.

    Do not use

    - on wounds or damaged skin

    - if you are allergic to any ingredients of this product

    When using this product

    - use only as directed

    - avoid contact with the eyes, mucous membran, and rashes

    - wrap the bandage not too tight

    Stop use and ask a doctor if

    - Rash, itching, or excessive skin irritation develops

    - conditions worsen

    - symptoms persist for more than 7 days

    - symptoms clear up and occur again within a few days

    If pregnant or breas-feeding

    - ask a health professional before use.

  • Keep out of reach of children

    Keep out or reach of children

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

  • Directions

    Adults and children over 12 years of age

    - clean and dry affected area

    - remove patch from film

    - remove patch slowly and gentle from the skin after at most 8 hours application

    Children under 12 years of age:

    consult a doctor

  • Inactive ingredients

    Zinc oxide, Polybutene

  • Ageranium Patch

    geranium patch

  • INGREDIENTS AND APPEARANCE
    AGERANIUM PATCH 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71955-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.228 mg  in 99.13 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71955-100-028 in 1 BOX12/29/2017
    1NDC:71955-100-014 in 1 POUCH
    1NDC:71955-100-0099.13 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/29/2017
    Labeler - Entom Co., Ltd. (690106385)
    Registrant - Lanec Inc. (052790515)
    Establishment
    NameAddressID/FEIBusiness Operations
    Entom Co., Ltd.690106385manufacture(71955-100)
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