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Antiseptic - Medication Information

Product NDC Code 79903-151
Drug Name

Antiseptic

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 LIQUID
RxCUI drug identifier 1043619
Application Number M022
Labeler Name WALMART INC. (see also Equate)
Packages
Package NDC Code Description
79903-151-50 500 ml in 1 bottle, plastic (79903-151-50)
79903-151-75 1.5 ml in 1 bottle, plastic (79903-151-75)
79903-151-99 2 bottle, plastic in 1 package (79903-151-99) / 1.5 ml in 1 bottle, plastic
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient 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 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, alcohol (21.6% v/v), sorbitol, poloxamer 407, flavor, sodium benzoate, benzoic acid, sodium saccharin, FD&C green #3

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 helps prevent and reduce plaque gingivitis

Purpose

Information about the drug product’s indications for use.
Purposes Antiplaque/antigingivitis

Spl product data elements

Usually a list of ingredients in a drug product.
Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 SODIUM BENZOATE BENZOIC ACID SACCHARIN SODIUM

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 Compare to Listerine® Cool Mint® active ingredient* Antiseptic Mouthwash Blue Mint Kills germs that cause plague, gingivitis, bad breath Helps to control and prevent plague that leads to gingivitis Eucalyptol (0.092%) Menthol (0.042%) Methyl salicylate (0.060%) Thymol (0.064%) Antiplaque/antigingivitis L (QT PT FL OZ) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine® Cool Mint®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 Package label EQUATE Antiseptic Mouthwash Blue Mint Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)

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 in children under 12 years of age.

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 under 6 years of age If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store at room temperature cold weather may cloud this product. Its antiseptic properties are not affected. this rinse is not intended to replace brushing or flossing

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 1-888-287-1915

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 gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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.
Warning Do not use in children under 12 years of age. Stop use and ask a dentist gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

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