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Antispetic - Medication Information

Product NDC Code 76162-567
Drug Name

Antispetic

Type Brand
Active Ingredients
Eucalyptol .92 mg/ml
Menthol .42 mg/ml
Methyl salicylate .6 mg/ml
Thymol .64 mg/ml
Route ORAL
Dosage Form MOUTHWASH
RxCUI drug identifier 1043619
Application Number 505G(a)(3)
Labeler Name Topco
Packages
Package NDC Code Description
76162-567-86 1000 ml in 1 bottle, plastic (76162-567-86)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

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 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor

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.
Use help control plaque that leads to gingivitis

Purpose

Information about the drug product’s indications for use.
Purpose Antigingivitis, Antiplaque

Spl product data elements

Usually a list of ingredients in a drug product.
Antispetic Eucalyptol, menthol, methyl salicylate, thymol WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL

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 everyday DYE FREE Antiseptic Mouthwash ANTIGINGIVITIS/ANTIPLAQUE REFRESHING MINT Kills 99% of germs commonly associated with gingivitis Freshens breath With essential oils Sugar free 33.8 FL OZ (1QT 1.8 FL OZ) 1 L image description

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
DISTRIBUTED BY TOPCO ASSOCIATES, LLC ELK GROVE VILLAGE, IL 60007 TOPCO VIJA1121 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for mroe information or call 1-888-423-0139 Claims QUALITY GUARANTEED This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

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. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
TEP SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Call 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 dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Storage and handling

Information about safe storage and handling of the drug product.
Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

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 for this product

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

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