ANTISEPTIC MOUTHRINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic Mouthrinse by

Drug Labeling and Warnings

Antiseptic Mouthrinse by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC, Consumer Product Partners, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

Sealed With Printed Neckband For Your Protection

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

Helps control plaque that leads to gingivitis

Warnings

For this product

Do not use if

you have painful or swollen gums, pus from the gum line, loose teeth or incresed spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

gingivitis, bleeding, or rednss persists for more than 2 weeks

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children under 12 years if age and older - vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

• this rinse is not intended to replace brushing or flossing

Other information

cold weather may cloud this product.  Its antiseptic propeties are not affected.  Store at room temperature (59° -77° F)

Inactive ingredients

water, alcohol (21.6 %), sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst ®Listerine Antiseptic Mouthwash.

Adverse reaction

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-844-846-9949

©2018 S&S Brands, LLC

Quality Guaranteed or Your Money Back

Principal display panel

careone ®

Compare to FreshBurst ®Listerine ® Antiseptic Mouthwash*

ANTISEPTIC MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND THE GUM DISEASE GINGIVITIS

SPRING MINT ®

33.8 FL OZ (1.05 QT) 1L

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTHRINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-072
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	0.6 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: 72476-072-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2010
2	NDC: 72476-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2010
3	NDC: 72476-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2010
4	NDC: 72476-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/18/2010

Labeler - Retail Business Services, LLC (967989935)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72476-072)