FDA Label for Sore Throat
View Indications, Usage & Precautions
Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Safeway, 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
temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation
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 Dentist Or Doctor If
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 6 years of age and older
- apply to affected area (one spray)
- allow to remain in place for at least 15 seconds, then spit out
- use every 2 hours as directed by a doctor or dentist
- children under 12 years of age should be supervised in the used in this product
- children under 6 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, glycerin, flavor, purified water, saccharin sodium anhydrous
Questions Or Comments?
Call 1-888-723-3929 Monday-Friday 7AM-6PM PST
Principal Display Panel
Sore Throat Spray
PHENOL 1.4 %
Oral Anesthetic / Analgesic
Cherry flavor
- Alcohol 0.10%
- Aspirin free
- Sugar free
FL OZ (mL)
COMPARE TO Chloraseptic® active ingredient*
*This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
BETTER LIVING BRAND LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Package Label
Signature Care Sore Throat Spray Cherry
* Please review the disclaimer below.