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3 Part Acne Treatment Kit Ceela Naturaals

Medically reviewed on October 9, 2017

Dosage form: kit
Ingredients: SALICYLIC ACID 20mg in 1mL;
Labeler: Ceela Naturals, LLC
NDC Code: 42021-035

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.

three part acne kit

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

Established Pharmacological Class
SubstancePharmacological Class
ToneCleansing (cold creams, cleansing lotions, liquids, and pads)
3 PART ACNE TREATMENT KIT  CEELA NATURAALS
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42021-035
Packaging
#Item CodePackage Description
1NDC:42021-035-111 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 PACKAGE, COMBINATION 1 mL
Part 20 PACKAGE, COMBINATION 1 mL
Part 30 PACKAGE, COMBINATION 1 mL
Part 1 of 3
ACNE GEL WASH 
salicylic acid gel
Product Information
Item Code (Source)NDC:42021-031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOTRIENOL 
WATER 
ISOMERIZED SAFFLOWER ACID 
POTASSIUM HYDROXIDE 
ASPARTIC ACID 
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
11 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION
1NDC:42021-031-02150 mL in 1 PACKAGE, COMBINATION
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D
Part 2 of 3
CLEAR SALVE-50 
salicylic acid salve
Product Information
Item Code (Source)NDC:42021-032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOMERIZED SAFFLOWER ACID 
ASPARTIC ACID 
POTASSIUM HYDROXIDE 
NIACINAMIDE 
GLYCINE 
TOCOTRIENOL 
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
11 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION
1NDC:42021-032-0450 mL in 1 PACKAGE, COMBINATION
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D
Part 3 of 3
TONE 
Product Information
Ingredients
Ingredient NameQuantity
WATER 
WITCH HAZEL 
ISOMERIZED SAFFLOWER ACID 
POTASSIUM ASPARTATE 
TOCOTRIENOL 
Packaging
#Item CodePackage Description
11 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION
1118 mL in 1 PACKAGE, COMBINATION
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph final333D10/09/2017
Labeler - Ceela Naturals, LLC (833224822)
Registrant - Ceela Naturals, LLC (833224822)
Establishment
NameAddressID/FEIOperations
Ceela Naturals, LLC833224822manufacture(42021-032, 42021-035), label(42021-031, 42021-031, 42021-032, 42021-035), pack(42021-031, 42021-032, 42021-035)

 
Ceela Naturals, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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