Label: ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash
- NDC Code(s): 11822-0072-1, 11822-0072-2
- Packager: Rite Aid
- 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 January 31, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash
OUT PROMISE:
Gluten Free - Sugar Free - Paraben Free
DISTRIBUTED BY:
Rite Aid, 30 Hunter Lane,
Camp Hill, PA 17011
www.RiteAid.com
SATISFACTION GUARANTEE
If you're not saisfied, we';; happily refund your money.
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principal display panel
Sealed with printed neckband for your protection
*Compare to FreshBurst Listerine Antiseptic Mouthwash
FREE FROM GLUTEN, SUGAR
ANTISEPTIC
MOUTHWASH
ANTIGINGIVITIS/ANTIPLAQUE RINSE
FRESH MINT
helps reduce plaque & gingivitis
fights bad breath
child-resistant cap
ADA Accepted
American Dental Association
- Helps reduce plaque
- Helps reduce gingivitis
1L (1.05 QT) 33.8 FL OZ
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INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0072 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:11822-0072-1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/1997 2 NDC:11822-0072-2 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/1997 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-0072) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-0072)