Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 75981-664-12, 75981-664-13, 75981-664-69 - Packager: Geiss, Destin + Dunn, Inc.
- 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 February 25, 2013
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- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- Stop use
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Adverse Reactions
- Disclaimer
- Adverse Reactions
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NDC 75987-664-13
Antiseptic
Mouth Rinse
Blue Mint
ADA
Accepted
American
Dental
Associatin
Kills Germs That Cause
Bad Breath, Plaque + The Gum
Disease Gingivitis
Compare to active ingredients of
Listerine
Sealed With Printed Neckband For Your Protection
1.25 LITER (42.3 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75981-664 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 BENZOATE (UNII: OJ245FE5EU) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75981-664-13 1250 mL in 1 BOTTLE, PLASTIC 2 NDC:75981-664-12 1500 mL in 1 BOTTLE, PLASTIC 3 NDC:75981-664-69 250 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/01/1992 Labeler - Geiss, Destin + Dunn, Inc. (076059836) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(75981-664)