[de-listing] TIESO FOR MAN SOOTHING CREAM (4 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 (4 ml)

TIESO FOR MAN SOOTHING 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73184-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.044 g  in 4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73184-0004-1	4 mL in 1 POUCH; Type 0: Not a Combination Product	08/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/21/2019	10/22/2021

Labeler - ANDIVA Inc. (695032533)

Registrant - ANDIVA Inc. (695032533)

Establishment
Name	Address	ID/FEI	Business Operations
ATEC CO., LTD.		689276681	manufacture(73184-0004)

Revised: 10/2021

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

34390-5

Set id: b4c29eac-8ac6-1630-e053-2a95a90af237

Version: 2

Effective Time: 20211022