SPL v1
SPL
SPL Set ID b138f8f2-f994-2b66-e053-2995a90aa8e9
Route
TOPICAL
Published
Effective Date 2020-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-10-09

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

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

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)