Label: TROFRESH- sorbitol, glycerin spray

  • NDC Code(s): 58354-106-01, 58354-106-02
  • Packager: Cho-A Pharm.Co.,Ltd.
  • 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 21, 2018

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

  • 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)