Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 72036-072

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter for the product Antiseptic Mouth Rinse (NDC 72036-072). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Other

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients
Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Otc - Purpose

Purpose
Antigingivitis, Antiplaque

Indications & Usage

Use helps control plaque that leads to gingivitis

Warnings

Otc - Do Not Use

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See you dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Otc - Stop Use

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

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

Storage And Handling

Other information cold weather may cloud this product. It antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F)

Inactive Ingredient

Inactive ingredients water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D&C yellow, FD&C green no. 3