FDA Label for Chloraseptic Warming Sore Throat

View Indications, Usage & Precautions

Chloraseptic Warming Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Phenol 1.4%


Purpose



Oral anesthetic/Analgesic


Uses



For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.


Warnings



Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.


When Using This Product



do not exceed recommended dosage.


Stop Use And Ask A Doctor Or Dentist 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 (1-800-222-1222) right away.


Directions



  • Adults and children 6 years of age and older:
  • 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 or dentist.
    Children under 12 years of age should be supervised in the use of this product.
    Children under 3 6 years of age: consult a doctor or dentist.

Other Information



  • Store at room temperature.
  • Check expiration date before using.
  • Contains FD&C yellow 5 (tartrazine) as a color additive

Inactive Ingredients



caramel color, citric acid, FD&C yellow no. 5, FD&C yellow no.6, glycerin, flavors, purified water, saccharin sodium, sodium citrate, sucralose


Questions?



1-800-552-7932 Chloraseptic.com


Principal Display Panel



Chloraseptic Warming Sore Throat Spray
Phenol/Oral Anesthetic

Honey Lemon
Flavor | 6 FL OZ (177 mL)


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