SPL v1
SPL
SPL Set ID b2009151-c15a-6001-e053-2995a90a4796
Route
TOPICAL
Published
Effective Date 2020-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.005 g)
Inactive Ingredients
Water Glycerin Verbena Officinalis Arginine Propylene Glycol Cetylpyridinium Chloride Methyl Salicylate Sorbitol Poloxamer 407 Butylene Glycol Sodium Benzoate Prunus Speciosa Flower Sucralose Menthol Polysorbate 20 Citric Acid Monohydrate Menthone 1,2-glycerol Ketal, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-10-19

Description

Keep in a cool and dry place and aviod storage in direct sunlight.


Medication Information

Warnings and Precautions

Stopuse and aska doctor when feelinguncomfortable.

Indications and Usage

It is recommended to use one(10ml) at a time, gargle for 30 seconds and spit out It's no need to garglewith water after use.

Dosage and Administration

Keep in a cool and dry place and aviod storage in direct sunlight.

Description

Keep in a cool and dry place and aviod storage in direct sunlight.

Section 50565-1

keep out of reach of children

Section 50570-1

Don't swallow it.

Section 51727-6

AQUA、SORBITOL、GLYCERIN、POLOXAMER 407、PRUNUS SPECIOSA FLOWER EXTRACT、VERBENA OFFICINALIS EXTRACT、MENTHOL、 MENTHONE GLYCERIN ACETAL、ARGININE、SUCRALOSE、PROPYLENE GLYCOL、 BUTYLENE GLYCOL、POLYSORBATE 20、CETYLPYRIDINIUM CHLORIDE、CITRIC ACID、 FLAVOR、SODIUM BENZOATE

Section 51945-4

Section 55105-1

gargle

Section 55106-9

SODIUM FLUORIDE


Structured Label Content

Indications and Usage (34067-9)

It is recommended to use one(10ml) at a time, gargle for 30 seconds and spit out It's no need to garglewith water after use.

Dosage and Administration (34068-7)

Keep in a cool and dry place and aviod storage in direct sunlight.

Warnings and Precautions (34071-1)

Stopuse and aska doctor when feelinguncomfortable.

Section 50565-1 (50565-1)

keep out of reach of children

Section 50570-1 (50570-1)

Don't swallow it.

Section 51727-6 (51727-6)

AQUA、SORBITOL、GLYCERIN、POLOXAMER 407、PRUNUS SPECIOSA FLOWER EXTRACT、VERBENA OFFICINALIS EXTRACT、MENTHOL、 MENTHONE GLYCERIN ACETAL、ARGININE、SUCRALOSE、PROPYLENE GLYCOL、 BUTYLENE GLYCOL、POLYSORBATE 20、CETYLPYRIDINIUM CHLORIDE、CITRIC ACID、 FLAVOR、SODIUM BENZOATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

gargle

Section 55106-9 (55106-9)

SODIUM FLUORIDE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)