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| Product NDC Code | 36800-606 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare sore throat menthol flavor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 198776 | ||||
| Application Number | M022 | ||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Phenol 1.4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ▪ Adults and children 12 year 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 or as directed by a doctor or dentist ▪ 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C Green No.3, D&C Green No. 5, D&C Yellow No.10, flavor, glycerin, purified water, sucralose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporarily relieves of occasional minor irritation, pain, sore mouth and sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic/analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Topcare Sore Throat Menthol Flavor Phenol PHENOL PHENOL FD&C GREEN NO. 3 D&C GREEN NO. 5 D&C YELLOW NO. 10 GLYCERIN WATER SUCRALOSE clear
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 TopCare Sore Throat Spray Menthol Flavor
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-423-0139
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not exceed recommended dosage.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature • Check expiration date before using.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API