SSENCARE- menthol liquid 
MIKYEONG KOREA 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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Menthol

Vanillyl Butyl Ether, Water, etc

Warming & Relaxing, Calming

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.

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

for external use only

label

SSENCARE 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72506-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72506-0001-130 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2021
2NDC:72506-0001-280 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/06/2021
3NDC:72506-0001-3100 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/06/2021
Labeler - MIKYEONG KOREA CO.,LTD (694790921)
Registrant - MIKYEONG KOREA CO.,LTD (694790921)
Establishment
NameAddressID/FEIBusiness Operations
MIKYEONG KOREA CO.,LTD694790921label(72506-0001) , pack(72506-0001) , manufacture(72506-0001)

Revised: 4/2021
Document Id: bf4b4ac4-e7dc-bbe0-e053-2995a90a8660
Set id: 74120180-7653-6677-e053-2a91aa0ae122
Version: 2
Effective Time: 20210406
 
MIKYEONG KOREA CO.,LTD