FDA Label for Chloraseptic Sore Throat Citrus
View Indications, Usage & Precautions
Chloraseptic Sore Throat Citrus 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%
Phenol 1.4%
Phenol 1.4%
Purpose
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Uses
For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
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.
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.
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.
do not exceed recommended dosage.
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
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- 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.
ask a health care professional before use.
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.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
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.
- 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.
- 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.
Adults and children 3 years of age and older:
Adults and children 3 years of age and older:
Other Information
- store at room temperature
- check expiration date before using.
- store at room temperature
- check expiration date before using.
- store at room temperature
- check expiration date before using
Inactive Ingredients
Citric acid, FD&C Red #40, FD&C Yellow #6, flavor, glycerin, purified water, sodium saccharin, sodium citrate
FD&C red no. 40, flavors, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin, sucralose
D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, sodium saccharin, sucralose
Questions?
1-800-552-7932 Chloraseptic.com
Drug Facts
1-800-552-7932 Chloraseptic.com
Drug Facts
1-800-552-7932 Chloraseptic.com
Principal Display Panel
Chloraseptic® Phenol/Oral Anesthetic
SOOTHING CITRUS| 6 FL OZ (177 mL)
Chloraseptic® Phenol/Oral Anesthetic
CHERRY Flavor
6 FL OZ (177 mL)
Chloraseptic® Phenol/Oral Anesthetic
MENTHOL Flavor| 6 FL OZ (177 mL)
Chloraseptic® Phenol/Oral Anesthetic
CHERRY Flavor
0.67 FL OZ (20 mL)
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