MOUTHWASH- eucalyptol, menthol, methyl salicylate, thymol liquid

Mouthwash by

Drug Labeling and Warnings

Mouthwash by is a Otc medication manufactured, distributed, or labeled by DISCOUNT DRUG MART, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Thymol 0.064%

Purpose

Antiplaque/Antigingivitis

Uses

to help reduce and prevent plaque and gingivitis.

Warnings

Do not use for children under 12 years of age.

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

• rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
• Do not swallow.

Other Information

• store at room temperature.
• cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingreduebts

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Package Principal Display Panel

INGREDIENTS AND APPEARANCE

MOUTHWASH 
eucalyptol, menthol, methyl salicylate, thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-514
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-514-50	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/01/2021

Labeler - DISCOUNT DRUG MART (047741335)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(53943-514)