TROFRESH- sorbitol, glycerin spray

Trofresh by

Drug Labeling and Warnings

Trofresh by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co.,Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TROFRESH 
sorbitol, glycerin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58354-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)	SORBITOL	0.06 g  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.087 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58354-106-02	1 in 1 PACKAGE	02/21/2018
1	NDC: 58354-106-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/21/2018

Labeler - Cho-A Pharm.Co.,Ltd. (688056831)

Registrant - Cho-A Pharm.Co.,Ltd. (688056831)

Establishment
Name	Address	ID/FEI	Business Operations
Cho-A Pharm.Co.,Ltd.		688056831	manufacture(58354-106)