Label: TROFRESH- sorbitol, glycerin spray
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- 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.
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- Active ingredients
- Purpose
- Uses
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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 medicineIf 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
- Inactive ingredients
- Keep out of reach of children
- Trofresh Spray
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INGREDIENTS AND APPEARANCE
TROFRESH
sorbitol, glycerin sprayProduct 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)
