Label: MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 59450-901-86
- Packager: Kroger
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 21, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- Stop use and ask a dentist if
- Keep out of reach of children.
-
Directions
adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds 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
- this rinse is not intended to replace brushing or flossing
- Other information
- Inactive ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
-
Principal Panel Display
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
simple truth
Breath & Gum Cleanser
ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH
WITH ESSENTIAL OILS
HERBAL MINT
fights bad breath
helps prevent plaque & gingivitis
imrproves oral hygiene
for refreshing oral care
NO ARTIFICIAL SWEETNERS OR DYES
NO POLYETHYLENE GLYCOL
33.8 FL OZ (1.05 QT) 1L
-
INGREDIENTS AND APPEARANCE
MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59450-901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Eucalyptol (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) Eucalyptol .92 mg in 1 mL Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol .42 mg in 1 mL Methyl salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl salicylate .60 mg in 1 mL Thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) Thymol .64 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) sorbitol (UNII: 506T60A25R) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) benzoic acid (UNII: 8SKN0B0MIM) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) sodium benzoate (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59450-901-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/21/2023 Labeler - Kroger (006999528) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(59450-901) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(59450-901)