Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 55910-099-12, 55910-099-69, 55910-099-77
- Packager: Old East Main CO
- 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 October 3, 2023
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- 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
- other information
- Inactive ingredients
-
ADVERSE REACTIONS
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Since 1903 Rexall is a registered
trademark of Rexall Sundown, Inc.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOOLETTSVILLE, TN 37072
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DSP-TN-21091
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-099 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.60 mg in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg in 1 mL 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 CITRATE (UNII: 1Q73Q2JULR) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-099-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2004 2 NDC:55910-099-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2004 3 NDC:55910-099-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/19/2004 Labeler - Old East Main CO (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-099) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-099)