FAMILY DOLLAR ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
Family Dollar

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.

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FAMILY DOLLAR ANTISEPTIC MOUTH WASH

Active ingredient: Purpose
Eucalyptol 0.092%, Menthol 0.042%....................Antigingivitis, Antiplaque

Methyl Salicylate 0.060%, Thymol 0.064%...........Antigingivitis, Antiplaque

USE: Helps control plaque that leads to gingivitis.

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.

Warnings

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased 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 redness persists for more than 2 weeks.

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

- this rinse is not intended to replace brushing or flossing

Directions

adults and children 12 years of 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

Other information cold weather may cloud this product. Its antiseptic properties are not

affected . Store at room temperature (59 - 77 F)

Inactive Ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

image of label

FAMILY DOLLAR ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-132
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.092 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.042 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.06 g in 100 g
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.064 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55319-132-01	1205 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/16/2011	12/20/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/16/2011	12/20/2017

Labeler - Family Dollar (024472631)

Name	Address	ID/FEI	Business Operations
Establishment
Willard Manufacturing Inc.		208799143	manufacture(55319-132)

Revised: 12/2017

Document Id: 60cb9e21-d4a7-210d-e053-2a91aa0ace8b

Set id: 458c3e1b-1165-4fd2-b036-5226eef31091

Version: 3

Effective Time: 20171220

Family Dollar