Active Ingredient
Phenol 1.4%
Topcare Sore Throat Spray
FDA Label NDC 36800-606
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Sore Throat (NDC 36800-606). 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 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
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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
* Please review the disclaimer below.
