TROFRESH (SORBITOL, GLYCERIN) SPRAY [CHO-A PHARM.CO.,LTD. ]

TROFRESH (SORBITOL, GLYCERIN) SPRAY [CHO-A PHARM.CO.,LTD. ]
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NDC 58354-106-01, 58354-106-02
Set ID 65b6c08d-ebfc-832f-e053-2991aa0ac81e
Category HUMAN OTC DRUG LABEL
Packager Cho-A Pharm.Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART356
  • Active ingredients

    D-Sorbitol (20g/100ml)

    Glycerin (29g/100ml)

  • Purpose

    Oral Pain Reliever

    Oral demulcents

  • Uses

    For the temporarily relief of:

    occasional minor irritation, pain, sore mouth, and sore throat

  • Warnings

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly.

    Stop use and ask a doctor if

    - following symptoms after use: irritation inside mouth, skin rash rube faction, itchiness

    - symptoms worsen

    - no improvement in symptom after 5-6 days of use

    Ask doctor the people who

    - is being treated by a physician or dentist
    - have severe erosion inside the mouth
    - is patient or family member having allergy
    - have history of allergic reaction to medicine

    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 (1-800-222-1222) right away.

    Do not exceed recommended dosage.

    When using this product

    - if used while inhaling, the medicine may enter bronchial tube or lung, so face the nozzle to affected area in the throat, say ‘ah’ while spraying.
    - use it for spraying in the throat, but do not take it internally.
    for use in children, use under parent or guardian’s instruction and supervision.
    - Be careful not to get the medicine in the eyes. If it does, immediately wash with water, and consult an ophthalmologist.
    - After using this medicine, alcohol may be detected above the concentration for drunk driving for a certain amount of time, so please avoid using it while driving

  • Directions

    • Pull the nozzle cap forward to remove
    • Face the nozzle and spray moderate amount to the affected area multiple times a day
    • Close the nozzle cap to store
  • Inactive ingredients

    Soluble Azulene, Methylparaben, Propylparaben, L-Menthol, Ethanol, Polypropylene Glycol, Citric Acid Hydrate, Sodium Citrate Hydrate, Sodium Hydroxide, Banana Essence S, Purified Water

  • Keep out of reach of children

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

  • Trofresh Spray

    trofresh spray

  • INGREDIENTS AND APPEARANCE
    TROFRESH 
    sorbitol, glycerin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL0.06 g  in 30 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.087 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58354-106-021 in 1 PACKAGE02/21/2018
    1NDC:58354-106-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/21/2018
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cho-A Pharm.Co.,Ltd. 688056831manufacture(58354-106)

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