ABOVE MOUTHWASH ANTISEPTIC- above mouthwash antiseptic mouthwash 
BASTON INDUSTRIA DE AEROSSOIS LTDA

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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Above Mouthwash Antiseptic

MENTHOL - 0,3
METHYL SALICYLATE - 0,25

CETYLPYRIDINIUM CHLORIDE - 0,075

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

anticavity
antiplaque

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

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

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

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

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.

label

ABOVE MOUTHWASH ANTISEPTIC 
above mouthwash antiseptic mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73306-1160
Route of AdministrationDENTAL, BUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.25 mg  in 500 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.3 mg  in 500 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.075 mg  in 500 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73306-1160-1500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02107/24/2023
Labeler - BASTON INDUSTRIA DE AEROSSOIS LTDA (897727605)
Registrant - BASTON INDUSTRIA DE AEROSSOIS LTDA (897727605)
Establishment
NameAddressID/FEIBusiness Operations
BASTON INDUSTRIA DE AEROSSOIS LTDA897727605manufacture(73306-1160)

Revised: 7/2023
Document Id: 013d6133-cf6f-9c15-e063-6294a90a53e7
Set id: 013d6133-cf6e-9c15-e063-6294a90a53e7
Version: 1
Effective Time: 20230724
 
BASTON INDUSTRIA DE AEROSSOIS LTDA