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| Product NDC Code | 79903-152 | ||||||||
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| Drug Name | Antiseptic |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1043619 | ||||||||
| Application Number | M022 | ||||||||
| Labeler Name | WALMART INC. (see also Equate) | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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, sodium benzoate, benzoic acid, sodium saccharin, flavor, D&C yellow #10, 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 FD&C GREEN NO. 3 D&C YELLOW NO. 10
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® Freshburst® active ingredients* Antiseptic Mouthwash Green Mint Kills germs that cause plaque, gingivitis bad breath Help to control and prevent plaque 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® Freshburst®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Package label EQUATE Antiseptic Mouthwash Green 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