Label: ANTISEPTIC- eucalyptol,menthol, methyl salicylate, thymol rinse
- NDC Code(s): 49348-482-62, 49348-482-89
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 December 16, 2021
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- Active ingredients
For this product
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
- Other information
- Inactive ingredients
The ADA council on Scientific affairs Acceptance of Sunmak's Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline when used as directed.
This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine.
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INGREDIENTS AND APPEARANCE
eucalyptol,menthol, methyl salicylate, thymol rinse
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-482 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL .092 kg in 100 L MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .042 kg in 100 L METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE .060 kg in 100 L THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL .064 kg in 100 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-482-62 1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/1990 08/04/2023 2 NDC:49348-482-89 1.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/1990 08/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/15/1990 08/04/2023 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(49348-482)