Active Ingredient
Phenol 1.4%
Chloraseptic Childrens Sore Throat Cherry Spray
FDA Label NDC 67172-930
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Chloraseptic Childrens Sore Throat Cherry (NDC 67172-930). 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 or dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
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 dose.
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
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
- Adults and children 3years 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 between 20°-25°C (68°- 77°F)
- do not refrigerate
Inactive Ingredients
alcohol, FD&C red #40, flavor, glycerin, purified water, sodium saccharin anhydrous
Principal Display Panel
Chloraseptic
children’s
Sore Throat
safe for 3+
Fast acting relief
cherry-licious
6 FL OZ (177 mL) SPRAY
Chlorasepticchildren’ssore Throatsafe For 3+fast Acting Reliefcherry-licious6 Fl Oz (177 mL) Spray (Chloraseptic Childrens Sore Throat Spray Cherry 01)
* Please review the disclaimer below.
