3 PART ACNE TREATMENT KIT CEELA NATURAALS- salicylic acid kit

3 Part Acne Treatment Kit by

Drug Labeling and Warnings

3 Part Acne Treatment Kit by is a Otc medication manufactured, distributed, or labeled by Ceela Naturals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

USEs

treating acne
dries up acne pimples helps prevent new acne pimples

Warnings

Keep out of Reach of Children If swallowed get medical help or contact POISON CONTROL right away

For external use only.
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

When using this product rinse right away with water if it gets in eyes. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Keep out of reach of children If swallowed get medical help or contact POISON CONTROL right away.

Directions

Squeeze a small amount into the palm of your hand and create a slight lather using cool or warm water. Gently massage the lather over your face or body for approximately 30 seconds. Avoid the delicate eye area. Rinse thoroughly. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other

Store at 15-30°C (59-86°F)

Questions? Call: 800 624 4532 or visit our website at skinbyceela.com

manufactured and distributed by

Ceela Naturals, LLC

Louisville, KY 40203

Inactive Ingredients

Inactive Ingredients: Purified water, isomerized linoleic acid (CLA from Safflower), potassium hydroxide, Aspartate, Oryza sativa extract (Rice Vit E Tocotrienol).

Active Ingredient

2% Salicylic Acid

Purpose

Acne, Psoriasis and Seborrheic Dermatitis Treatment

USES

treating acne

dries up acne pimples

helps prevent new acne pimples

eliminates seborrhea and dandruff

helps itching, redness, scaling

Warnings

For external use only.

Avoid contact with eyes. If contact occurs rinse right away with water.

If condition worsens or does not improve after regular use, see a doctor.

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Keep out of reach of children.

Keep out of reach of children If swallowed get medical help or contact POISON CONTROL right away.

Directions

Pump into the palm of your hand. Spread on affected area one to four times daily or as directed by a doctor. If condition covers a large area, consult a doctor.

Other information

Store at 15-30°C (59-86°F)

Questions? Call: 800 624 4532 or visit our website at ceelanaturals.com

manufactured and distributed by

Ceela Naturals, LLC

Louisville, KY 40203

Inactive Ingredients

Inactive Ingredients: Purified water, isomerized linoleic acid (CLA from Safflower), potassium hydroxide, Aspartate, Niacinamide, Oryza sativa extract (Rice Vit E Tocotrienol).

package label

INGREDIENTS AND APPEARANCE

3 PART ACNE TREATMENT KIT   CEELA NATURAALS
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42021-035

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42021-035-11	1 in 1 PACKAGE, COMBINATION	10/09/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 PACKAGE, COMBINATION	1 mL
Part 2	0 PACKAGE, COMBINATION	1 mL
Part 3	0 PACKAGE, COMBINATION	1 mL

Part 1 of 3

ACNE GEL WASH 
salicylic acid gel

Product Information
Item Code (Source)	NDC: 42021-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOTRIENOL (UNII: 0867I0N41V)
WATER (UNII: 059QF0KO0R)
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ASPARTIC ACID (UNII: 30KYC7MIAI)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKAGE, COMBINATION
1	NDC: 42021-031-02	150 mL in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D

Part 2 of 3

CLEAR SALVE-50 
salicylic acid salve

Product Information
Item Code (Source)	NDC: 42021-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
ASPARTIC ACID (UNII: 30KYC7MIAI)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCINE (UNII: TE7660XO1C)
TOCOTRIENOL (UNII: 0867I0N41V)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKAGE, COMBINATION
1	NDC: 42021-032-04	50 mL in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D

Part 3 of 3

TONE 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	WITCH HAZEL (UNII: 101I4J0U34)
INGR	ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
INGR	POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
INGR	TOCOTRIENOL (UNII: 0867I0N41V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKAGE, COMBINATION
1		118 mL in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	333D	10/09/2017

Labeler - Ceela Naturals, LLC (833224822)

Registrant - Ceela Naturals, LLC (833224822)

Establishment
Name	Address	ID/FEI	Business Operations
Ceela Naturals, LLC		833224822	manufacture(42021-032, 42021-035) , label(42021-031, 42021-031, 42021-032, 42021-035) , pack(42021-031, 42021-032, 42021-035)