Active Ingredient
Phenol 1.4%
Sore Throat Relief Spray
FDA Label NDC 68016-343
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium for the product Sore Throat Relief (NDC 68016-343). 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
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
If Pregnant Or Breast-Feeding,
ask a doctor before use.
Keep Out Of Reach Of Children.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Directions
- Apply to the affected area (one spray)
- Allow to remain in place for at least 15 seconds, then spit out
- Use every 2 hours or as directed by a doctor
Children under 12 years of age should be supervised in the use of this product
Children under 6 years of age: consult a doctor or dentist
Other Information
- Store at room temperature
- Check expiration date before using
Inactive Ingredients
D&C Green #5, D&C Yellow #10, FD&C Green #3, flavor, glycerin, purified water, sucralose
Principal Display Panel
*Compare to the active ingredient in Chloraseptic®*
Sore Throat Relief
Menthol Flavor
Fast acting relief of Minor Sore Throat and Mouth Pain
Phenol/Oral Anesthetic
Sugar-Free
Aspirin-Free
Gluten-Free
Alcohol-Free
6 FL OZ (177 mL)
*This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic®.
Tamper-Evident: Do not use if imprinted shrink band is broken or missing.
Distributed by:
Chain Drug Consortium LLC.
3301 N.W. Boca Raton Blvd.
Suite 101, Boca Raton FL 33431
* Please review the disclaimer below.
