SALON CODE GLAM HAIR COLOR GLAM ROSE GOLD- p-aminophenol kit

SALON CODE Glam Hair Color Glam Rose Gold by

Drug Labeling and Warnings

SALON CODE Glam Hair Color Glam Rose Gold by is a Otc medication manufactured, distributed, or labeled by Daolcosmetic Co.,ltd, Dong Sung Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

p-Aminophenol

INACTIVE INGREDIENT

ethanolamine, alcohol, butylene glycol, sodium sulfite, etc

PURPOSE

hair coloring

KEEP OUT OF REACH OF CHILDREN

Keep out or reach of the children

INDICATIONS & USAGE

First, wear gloves before starting the coloring session. Pour an equal amount of #1(colorant) & #2(developer) into the provided plastic container and close the cap until you hear the click sound. Mix well by shaking the container horizontally or sideways until the mixture turns to gel. (Do NOT shake the container vertically or up & down). Carefully open the container from the side and scoop the contents on hand to start the procedure. Use appropriate amounts as you color by sections to apply the gel to the top, sides, and the back. Gently rub the gel against hair. With the remaining gel, lightly apply along the hairline to finish the procedure. Wait according to the indicated time for the color to process (20min. to cover gray hair). After the desired color is obtained, wash and rinse several times with lukewarm water until water runs clear. NOTE: Leave extra 10 min. for thick hair and/or if the coloring procedure is done at cool temperature (below room temperature).

WARNINGS

For external use only.

This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test should first be made. This product must not be used for dyeing of eyelashes or eyebrows. If you were to do so, it may cause blindness. When product comes in contact with eyes during the coloring session, rinse immediately with cool, running water and consult a physician immediately. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Processed color may be different from the color chart indicated on the box due to condition of individual, hair, and/or temperature. Before coloring, please read the instructions thoroughly.

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALON CODE GLAM HAIR COLOR GLAM ROSE GOLD 
p-aminophenol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70778-0011

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70778-0011-1	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	70 mL
Part 2	1 BOTTLE	70 mL

Part 1 of 2

SALON CODE GLAM ROSE GOLD 
p-aminophenol liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
P-AMINOPHENOL (UNII: R7P8FRP05V) (P-AMINOPHENOL - UNII:R7P8FRP05V)	P-AMINOPHENOL	0.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		70 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/05/2018

Part 2 of 2

SALON CODE GLAM HAIR COLOR OXIDANT 
hydrogen peroxide liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	5.845 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		70 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/04/2018

Labeler - Daolcosmetic Co.,ltd (688279560)

Registrant - Daolcosmetic Co.,ltd (688279560)

Establishment
Name	Address	ID/FEI	Business Operations
Dong Sung Pharm Co., Ltd.		687811661	manufacture(70778-0011)

Establishment
Name	Address	ID/FEI	Business Operations
Daolcosmetic Co.,ltd		688279560	label(70778-0011)