CENTELLA SCAR YLANG YLANG- asiaticoside, madecassic acid, asiatic acid ointment
NoTS Co.,Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Asiaticoside 0.4%, Madecassic Acid 0.3%, Asiatic Acid 0.3%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Butylene Glycol, Dipropylene Glycol, Glyceryl Stearate SE, Glycerin, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Methylparaben, Triethanolamine, Carbomer, Cananga Odorata Flower Oil

PURPOSE

Purpose: Scar Treatment

WARNINGS

Warnings:

Stop use and ask dermatologist or doctor if

•signs of redness, skin swelling, itchy spots, irritation or rash and other appear

•the above signs appear in the applied area by direct rays of the sun

Do not use over wounds rashes inflammations other troubled areas.

Do not use more than instructed.

When using Avoid the eye area must close the cap after using

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses: For the treatment of scar

Directions

Directions: Apply appropriate and adequate amount of this product 1-2 times a day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CENTELLA SCAR YLANG YLANG
asiaticoside, madecassic acid, asiatic acid ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69716-250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Asiaticoside (UNII: PKO39VY215) (Asiaticoside - UNII:PKO39VY215)	Asiaticoside	0.06 g in 15 g
Madecassic Acid (UNII: M7O1N24J82) (Madecassic Acid - UNII:M7O1N24J82)	Madecassic Acid	0.045 g in 15 g
Asiatic Acid (UNII: 9PA5A687X5) (Asiatic Acid - UNII:9PA5A687X5)	Asiatic Acid	0.045 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69716-250-02	1 in 1 CARTON	12/01/2016	12/01/2018
1	NDC:69716-250-01	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/01/2016	12/01/2018

Labeler - NoTS Co.,Ltd (689004599)

Registrant - NoTS Co.,Ltd (689004599)

Name	Address	ID/FEI	Business Operations
Establishment
Nowcos.Co.,Ltd		689914984	manufacture(69716-250)

Revised: 12/2018

Document Id: fcbbd362-c5c2-42b2-99f5-b0585aaa9602

Set id: 4a735a5b-98cd-4dc1-a10d-0493fd4b1e21

Version: 3

Effective Time: 20181227

NoTS Co.,Ltd