Active Ingredient
Phenol 1.4%
Chloraseptic Warming Sore Throat Spray
FDA Label NDC 67172-212
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 Warming Sore Throat (NDC 67172-212). 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, 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
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
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Chloraseptic Warming Sore Throat Spray
Phenol/Oral Anesthetic
Honey Lemon Flavor | 6 FL OZ (177 mL)
Chloraseptic Warming Sore Throat Sprayphenol/oral Anesthetichoney Lemon Flavor | 6 Fl Oz (177 mL) (Chloraseptic Warming Sore Throat Spray 01)
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