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  5. Label Information: Chloraseptic Sore Throat

FDA Label for Chloraseptic Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR OR DENTIST IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL

Chloraseptic 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 0.5%


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 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 health care professional 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.


Directions



Adults and children 3 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 years of age: consult a doctor or dentist.

Other Information



  • Store at room temperature.
  • Check expiration date before using.

Inactive Ingredients



FD&C blue no. 1, FD&C red no.40, flavor, glycerin, purified water, sodium saccharin, sodium chloride


Questions?



1-800-552-7932 www.chloraseptic.com


Principal Display Panel



Kids Chloraseptic® 
Phenol/Oral Anesthetic
SORE THROAT
Real Relief, Real Fast®
GRAPE | 6 fl oz (177 mL)

Kids Chloraseptic® Phenol/Oral AnestheticSORE THROATReal Relief, Real Fast®GRAPE | 6 fl oz (177 mL) - chloraseptic sore throat grape spray 01

Kids Chloraseptic® Phenol/Oral AnestheticSORE THROATReal Relief, Real Fast®GRAPE | 6 fl oz (177 mL) - chloraseptic sore throat grape spray 01


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