TM-C7 Oral Care by Pharmacal-International Co., Ltd / Ecoworld Co., Ltd

TM-C7 Oral Care by

Drug Labeling and Warnings

TM-C7 Oral Care by is a Otc medication manufactured, distributed, or labeled by Pharmacal-International Co., Ltd, Ecoworld Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TM-C7 ORAL CARE- sodium fluoride liquid 
Pharmacal-International Co., Ltd

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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Active Ingredient

SODIUM FLUORIDE 0.02%

Purpose

Anticavity mouthwash

Warings

Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Uses

Aids in prevention of dental cavities. Use twice a day after brushing, meals, and before social occasions.

Directions

Rinse mouth with this TM-C7 Oral Care about 10~15ml for 30 seconds then expel

Inactive ingredients

Water,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract, fragrance, Sodium Saccharin,Lemon Oil,Cacao Color,Olive Leaf Extract,Sodium carbonate,Stevia

Keep out of reach of children

Children under 7 years or younger must have parent supervision.

TM-C7 ORAL CARE 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
ACETIC ACID (UNII: Q40Q9N063P)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MALIC ACID (UNII: 817L1N4CKP)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LEMON OIL (UNII: I9GRO824LL)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
SODIUM CARBONATE (UNII: 45P3261C7T)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-131-01	10 in 1 CARTON	03/05/2021	07/31/2023
1		800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/05/2021	07/31/2023

Labeler - Pharmacal-International Co., Ltd (557805060)

Establishment
Name	Address	ID/FEI	Business Operations
Ecoworld Co., Ltd		688735061	manufacture(24765-131)

Revised: 8/2023

Document Id: 021e481f-bcf2-811e-e063-6294a90a3a9b

34390-5

Set id: 8a97ad03-b3eb-4be0-9c8c-42d77a330184

Version: 3

Effective Time: 20230804