[de-listing] TIESO FOR MAN SOOTHING CREAM (70 ml)

TIESO FOR MAN SOOTHING by

Drug Labeling and Warnings

TIESO FOR MAN SOOTHING by is a Otc medication manufactured, distributed, or labeled by ANDIVA Inc., ATEC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIESO FOR MAN SOOTHING- dimethicone cream 
ANDIVA Inc.

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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[de-listing] TIESO FOR MAN SOOTHING CREAM (70 ml)

Active Ingredient

Dimethicone

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Lepidium Meyenii Root Extract, Niacinamide, 1,2-Hexanediol, Alcohol, Snail Secretion Filtrate , Octyldodeceth-16, Arginine, Carbomer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Chlorphenesin, Butylene Glycol, Sucrose Distearate , Hydroxyethylcellulose, Hydrogenated Lecithin, Glyceryl Acrylate/Acrylic Acid Copolymer, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Diospyros Kaki Leaf Extract, Morus Alba Root Extract, Disodium EDTA, Portulaca Oleracea Extract, Hyaluronic Acid, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Argania Spinosa Kernel Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Hydrolyzed Collagen, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Fragrance

TIESO FOR MAN SOOTHING 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73184-0700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.77 g  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ROSEMARY (UNII: IJ67X351P9)
PURSLANE (UNII: M6S840WXG5)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
NIACINAMIDE (UNII: 25X51I8RD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALCOHOL (UNII: 3K9958V90M)
OCTYLDODECETH-16 (UNII: RJV574G0DE)
ARGININE (UNII: 94ZLA3W45F)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYALURONIC ACID (UNII: S270N0TRQY)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CHAMOMILE (UNII: FGL3685T2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73184-0700-1	1 in 1 BOX	07/04/2019
1		70 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/04/2019	10/22/2021

Labeler - ANDIVA Inc. (695032533)

Establishment
Name	Address	ID/FEI	Business Operations
ATEC CO., LTD.		689276681	manufacture(73184-0700)

Revised: 10/2021

Document Id: ceea202d-472e-7ae7-e053-2995a90acd11

34390-5

Set id: b4c2c2f6-ac4f-5b47-e053-2a95a90a33a0

Version: 2

Effective Time: 20211022