ATO STANDARD INTENSIVECREAM- macadamia integrifolia seed oil, centella asiatica extract, panthenol, ceramide np cream

ATO STANDARD INTENSIVECREAM by

Drug Labeling and Warnings

ATO STANDARD INTENSIVECREAM by is a Otc medication manufactured, distributed, or labeled by TIMEBIO Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

MACADAMIA INTEGRIFOLIA SEED OIL 2%

CENTELLA ASIATICA EXTRACT 0.003%

PANTHENOL 0.75%

CERAMIDE NP 0.0006%

Purpose

Skin protectant

Uses

The unique formula protects skin by improving skin barrier and prevents moistureloss and revives skin itching due to dryness.

Nutritional oil revives smoothe-feeling skin texture and helps to achieve glowing skin.

Warnings

Direct sunlight.

Do not use children under 3 years of age

Do not use on wounds

Warnings

Discontinue use if irritation occurs.

Warnings

Keep out of reach of children.

Directions

Apply daily to skin needs special care like dry skin as needed and smooth to help absorption.

Inactive Ingredient

WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, BETAINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, NIACINAMIDE, CYCLOHEXASILOXANE, CETYL ALCOHOL, GLYCERYL STEARATE, BEHENYL ALCOHOL, TREHALOSE, LAMINARIA JAPONICA EXTRACT, ECLIPTA PROSTRATA LEAF EXTRACT, ACMELLA OLERACEA EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, SODIUM HYALURONATE, HYDROGENATED LECITHIN, WATER (and) HUMAN CORD BLOOD PROGENITOR CELL EXOSOMES, PENTAERYTHRITYL DISTEARATE, POLYGLYCERYL-10 LAURATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, ADENOSINE, FRUCTOOLIGOSACCHARIDES, DISODIUM EDTA, CITRIC ACID, BETA-GLUCAN, HYDROLYZED HYALURONIC ACID, CETEARYL ALCOHOL, GLYCERYL STEARATE SE, CHOLESTEROL, 1,2-HEXANEDIOL, FRAGRANCE, HYDROXYACETOPHENONE, ETHYLHEXYLGLYCERIN

Package Label

INGREDIENTS AND APPEARANCE

ATO STANDARD INTENSIVECREAM 
macadamia integrifolia seed oil, centella asiatica extract, panthenol, ceramide np cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81160-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MACADAMIA OIL (UNII: 515610SU8C) (MACADAMIA OIL - UNII:515610SU8C)	MACADAMIA OIL	2 g  in 100 g
CERAMIDE NP (UNII: 4370DF050B) (CERAMIDE NP - UNII:4370DF050B)	CERAMIDE NP	0.0006 g  in 100 g
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.75 g  in 100 g
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U)	CENTELLA ASIATICA WHOLE	0.003 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CHOLESTEROL (UNII: 97C5T2UQ7J)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LAMINARIA JAPONICA (UNII: WE98HW412B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
DOCOSANOL (UNII: 9G1OE216XY)
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BETAINE (UNII: 3SCV180C9W)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TREHALOSE (UNII: B8WCK70T7I)
ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
FIG (UNII: TGD87RII2U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81160-202-01	50 g in 1 TUBE; Type 0: Not a Combination Product	12/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/03/2020

Labeler - TIMEBIO Co., Ltd (695743093)

Registrant - TIMEBIO Co., Ltd (695743093)

Establishment
Name	Address	ID/FEI	Business Operations
TIMEBIO Co., Ltd		695743093	manufacture(81160-202)