TROFRESH- sorbitol, glycerin spray 
Cho-A Pharm.Co.,Ltd.

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.

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Trofresh Spray

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

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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
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 finalpart35602/21/201805/18/2023
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)

Revised: 5/2023
 
Cho-A Pharm.Co.,Ltd.