Label: CHO-A POINT PLASTER- methyl salicylate, l-menthol, dl-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 28, 2017

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

  • Active ingredients

    Methyl Salicylate (5.541mg)

    L-Menthol (2.769mg)

    Dl-Camphor (1.108mg)

  • Purpose

    Topical Analgesic

  • Directions

    Adults and children 12 years of age and over:

    - Apply to affected area once a day

    Children undress 12 years of age: consult a doctor

  • Inactive ingredients

    Mentha Oil, Tocopherol Acetate,Vanillyl nonylamide, Diphenhydramine, Hydrogenated C6-20 Polyolefin, Stylene · Isoprene · Stylene Block Copolymer, liquid paraffin, polyisobutylene, Butylated Hydroxy Toluene, non woven fabrics, polyethyleneterephthalate Separator

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Warnings

    For external use only

    Do not use on wounds or damaged skin

    - if you are allergic to any ingredients of this product

    - with a heating pad

    - with, or at the same time as, other external analgesic products

    When using this product

    - do not use otherwise than directed

    - avoid contact with eyes, mucous membranes or rashes

    - do not bandage tightly

    Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

    Stop use and ask a doctor if

    - rash, itching, or excessive skin irritation develops

    - conditions worsen

    - symptoms persist for more than 5-6 days

    - symptoms clear up and occur again within a few days

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

  • Uses

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

    - Arthritis

    - Simple backache

    - Strains

    - bruises

    - Sprains

  • Cho-A Point Plaster

    cho a point plaster draft

  • INGREDIENTS AND APPEARANCE
    CHO-A POINT PLASTER 
    methyl salicylate, l-menthol, dl-camphor patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.108 mg  in 67.15 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL2.769 mg  in 67.15 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE5.541 mg  in 67.15 mg
    Inactive Ingredients
    Ingredient NameStrength
    NONIVAMIDE (UNII: S846B891OR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58354-104-032 in 1 BOX12/28/2017
    1NDC:58354-104-0260 in 1 POUCH
    1NDC:58354-104-0167.15 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 finalpart34812/28/2017
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cho-A Pharm.Co.,Ltd. 688056831manufacture(58354-104)