FDA Label for Topcare Sore Throat Menthol Flavor
View Indications, Usage & Precautions
Topcare Sore Throat Menthol Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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
For the temporarily relieves 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 6 year of age unless directed by 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, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
▪ Adults and children 12 year of age and older:▪ Children under 12 years of age: Should be supervised in use of this product.▪ Children under 6 years of age: Ask a doctor or dentist
Apply to 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
Other Information
• store at room temperature• Check expiration date before using.
Inactive Ingredients
FD&C Green No.3, D&C Green No. 5, D&C Yellow No.10, flavor, glycerin, purified water, sucralose.
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare® health™
NDC# 36800-606-06
COMPARE TO THE CHLORASEPTIC® ACTIVE INGREDIENT*
SUGAR FREE
Sore Throat Spray
PHENOL / ORAL ANESTHETIC
• Works on Contact• Relieves Sore Throat Pain• Fast Acting
ASPIRIN FREE
ALCOHOL FREE
MENTHOL FLAVOR
OUR PHARMACIST RECOMMEND
6 FL OZ (177 mL)
QUALITY GUARANTEED
*This product is not manufactured or distributed by Prestige Brands Co., distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR TORN.
DISTRIBUTED BY TOPCO ASSOCIATESLLC,
ELK GROVE VILLAGE, IL 6007
TOPCO RARA1217
QUESTIONS? 1-888-423-0139
[email protected]www.tocarebrand.com
* Please review the disclaimer below.