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TENSION NO. 5

Medically reviewed on July 3, 2017

Dosage form: cream
Ingredients: WITCH HAZEL 0.0001mg in 50mL
Labeler: Maywell Co., Ltd.
NDC Code: 69628-010

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.

ACTIVE INGREDIENT

Active Ingredient: HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER 0.0002%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, BUTYLENE GLYCOL, ARGININE HCL, GLUTAMINE, LYSINE HCL, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED LECITHIN, HYALURONIC ACID, PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT, POLYSORBATE 80, COMMIPHORA MYRRHA LEAF CELL EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, JASMINUM SAMBAC (JASMINE) LEAF CELL EXTRACT, BIFIDA FERMENT LYSATE, RAFFINOSE, ARCTIUM LAPPA ROOT EXTRACT, PEG-60 HYDROGENATED CASTOR OIL, POLYQUATERNIUM-51, LECITHIN, GLYCERIN, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, SODIUM HYALURONATE, ANTHEMIS NOBILIS FLOWER WATER, BETA-GLUCAN, CENTAUREA CYANUS FLOWER WATER, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, INOSITOL, MAGNOLIA OFFICINALIS BARK EXTRACT, PSEUDOALTEROMONAS FERMENT EXTRACT, BHT, FRAGRANCE, PHELLINUS LINTEUS EXTRACT, ADENOSINE, DISODIUM EDTA, POTASSIUM SORBATE, FOLIC ACID, CERAMIDE 3, CHOLESTEROL, DIOSGENIN, ACETIC ACID, LACTIC ACID, ALCOHOL, TROMETHAMINE, PANTHENOL, PHENOXYETHANOL, DIPEPTIDE-2, COPPER TRIPEPTIDE-1, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8, PALMITOYL PENTAPEPTIDE-4, PALMITOYL TETRAPEPTIDE-7, ACETYL TRIPEPTIDE-1, PALMITOYL TRIPEPTIDE-1

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS & USAGE

Indications & Usage: After washing your face in the morning and evening, spray it on your face five time and on your neck three times as the first step of skin care. After patting it in gently with your hands, spray it on your face five times and on your neck three times again and let it absorb into the skin.

DOSAGE & ADMINISTRATION

Dosage & Administration: Five times in the face, neck three times

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TENSION NO. 5 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69628-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL0.0001 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:69628-010-0150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2015
Labeler - Maywell Co., Ltd. (689512503)
Registrant - Maywell Co., Ltd. (689512503)
Establishment
NameAddressID/FEIOperations
Maywell Co., Ltd.689512503relabel(69628-010)
Establishment
NameAddressID/FEIOperations
Kolmar Korea Co., Ltd.689512611manufacture(69628-010)

 
Maywell Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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