ABOVE MOUTHWASH ANTISEPTIC mouthwash

Above Mouthwash Antiseptic by

Drug Labeling and Warnings

Above Mouthwash Antiseptic by is a Otc medication manufactured, distributed, or labeled by BASTON INDUSTRIA DE AEROSSOIS LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL - 0,3
METHYL SALICYLATE - 0,25

CETYLPYRIDINIUM CHLORIDE - 0,075

INACTIVE INGREDIENT

AQUA, ALCOHOL, GLYCERIN, DIPROPYLENE GLYCOL, POLYSORBATE 20, SORBITOL, SODIUM BENZOATE, AROMA, SACCHARIN, SODIUM CHLORIDE, CI 42053

PURPOSE

anticavity
antiplaque

INDICATIONS & USAGE

AIDS IN THE PREVENTION OF DENTAL CAVITIES
USING THE PRODUCT EVERY 12 HORAS, YOU GET 24 HOUR OF PROTECTION

QUESTIONS

MAIL : SUPPORT@MYSPRAY.GROUP OR CALL (305) 677-5030

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OK. DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE. IF SWALLOWED SEED A DOCTOR. IF THE APPLIED AREA IS SENSITIVITY, SUSPEND USE AND SEED A DENTIST.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

20ML THEN SWISH FOR 30 SECONDS TWICE A DAY AFTER BRUSHING AND FLOSSING.

WARNINGS

KEEP OUT OF REACH OK. DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE. IF SWALLOWED SEED A DOCTOR. IF THE APPLIED AREA IS SENSITIVITY, SUSPEND USE AND SEED A DENTIST.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ABOVE MOUTHWASH ANTISEPTIC 
above mouthwash antiseptic mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73306-1160
Route of Administration	DENTAL, BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.25 mg  in 500 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.3 mg  in 500 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.075 mg  in 500 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73306-1160-1	500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M021	07/24/2023

Labeler - BASTON INDUSTRIA DE AEROSSOIS LTDA (897727605)

Registrant - BASTON INDUSTRIA DE AEROSSOIS LTDA (897727605)

Establishment
Name	Address	ID/FEI	Business Operations
BASTON INDUSTRIA DE AEROSSOIS LTDA		897727605	manufacture(73306-1160)