Active Ingredient
Phenol 1.4%
Sore Throat Relief Spray
FDA Label NDC 67091-267
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Sore Throat Relief (NDC 67091-267). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product,, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Anesthetic/Analgesic
Uses
temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.
When Using This Product,
do not use more than directed.
Stop Use And Ask A Doctor If
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
- difficulty in breathing occurs
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- apply to the affected area
- use every 2 hours
- allow to remain in place for at least 15 seconds, then spit out
| age | dose |
| adults and children 12 years and over | for each application, spray 5 times |
| children 3 to 11 years | should be supervised in use of this product for each application, spray 3 times |
| children under 3 years | ask a doctor or dentist |
Other Information
- store at 20°-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients
alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium
Questions?
Or to report an adverse event call 800-824-1706 Monday-Friday 9am-4pm MST
Principal Display Panel
*Compare to the active ingredient in Chloraseptic®*
Instant Acting
Sore Throat Relief
Phenol/Oral Anesthetic
Alcohol 0.10%
Relieves Sore Throat Pain
Cherry Flavor
Artificially Flavored
FL OZ (mL)
*This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.
DISTRIBUTED BY:
WINCO FOODS LLC
BOISE, ID 83704
*This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®
Package Label
WinCo Foods Sore Throat Relief Spray
* Please review the disclaimer below.
