Active Ingredient
Phenol 1.4%
Topcare Spray
FDA Label NDC 36800-600
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 (NDC 36800-600). 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 dentist or doctor 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 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 6 years of age unless directed by a doctor.
When Using This Product,
do not exceed recommended dosage.
Stop Use And Ask A Dentist Or Doctor 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 right away (1-800-222-1222).
Directions
▪ Adults and children 12 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 use of this product▪ Children under 6 years of age, Ask a doctor or dentist
Other Information
- Store at room temperature.
- Check expiration date before using.
Inactive Ingredients
FD&C Red No. 40, flavor, glycerin, purified water, sucralose.
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare® health™
COMPARE TO CHLORASEPTIC® ACTIVE INGREDIENT*
NDC# 36800-600-06
SUGAR-FREE
Sore Throat Spray
PHENOL/ORAL ANESTHETIC
- Works on Contact
- Relieves Sore Throat Pain
- Fast Acting
ASPIRIN-FREE
ALCOHOL-FREE
CHERRY FLAVOR
6 FL OZ (177 mL)
OUR PHARMACIST RECOMMEND
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 MISSING
DISTRIBUTED BY
TOPCO ASSOCIATES LLC,
ELK GROVE VILLAGE, IL 6007
TOPCO RARA1217
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
Package Label
TopCare Sore Throat Spray Cherry Flavor
* Please review the disclaimer below.
