SSENCARE- menthol liquid

SSENCARE by

Drug Labeling and Warnings

SSENCARE by is a Otc medication manufactured, distributed, or labeled by MIKYEONG KOREA CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol

INACTIVE INGREDIENT

Vanillyl Butyl Ether, Water, etc

PURPOSE

Warming & Relaxing, Calming

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Exercise before / after, except for sensitive areas, massage the appropriate amount as necessary

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SSENCARE 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72506-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72506-0001-1	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/23/2018
2	NDC: 72506-0001-2	80 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/23/2018
3	NDC: 72506-0001-3	100 mL in 1 TUBE; Type 0: Not a Combination Product	08/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/23/2018

Labeler - MIKYEONG KOREA CO.,LTD (694790921)

Registrant - MIKYEONG KOREA CO.,LTD (694790921)

Establishment
Name	Address	ID/FEI	Business Operations
MIKYEONG KOREA CO.,LTD		694790921	label(72506-0001) , pack(72506-0001) , manufacture(72506-0001)