SPECIAL CLEARING BOOSTER- benzoyl peroxide liquid

Special Clearing Booster by

Drug Labeling and Warnings

Special Clearing Booster by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., PakLab, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl Peroxide (5.0%).

Purpose

Acne treatment

Use

• treats acne

Warnings

For external use only

Stop use and ask a Doctor if too much skin irritation or sensitivity develops or increases

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if you

• have very sensative skin
• are sensative to benzoyl peroxide
• have broken skin

When using this product,

• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with the eyes, lips, and mouth.
• This product may bleach hair or dyed products.
• Using other topical acne drugs at the same time or right after use of this product may increase dryness or irriatation of the skin.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• 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 going outside, apply sunscreen after using this product. If irritation or sensativity develops, stop use of both products and ask a doctor.

Inactive ingredients

Water/Aqua/Eau, PEG-8, Polysorbate 20, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Calendula Officinalis Flower Extract, Anthemis Nobilis Flower Extract, Tilia Cordata Flower Extract, Centaurea Cyanus Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Flower/Leaf/Stem Extract, Nasturtium Officinale Flower/Leaf Extract, Arctium Lappa Root Extract, Salvia Officinalis (Sage) Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Hedera Helix (Ivy) Leaf/Stem Extract, Saponaria Officinalis Leaf/Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cyclodextrin, Hydrolyzed Algin, Silica, Zinc Sulfate, Benzophenone-4, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Butylene Glycol,Disodium EDTA, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol.

Other information

• Protect this product from excessive heat and direct sun

Questions or comments

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

special
clearing
booster

dermalogica®

acne treatment

mediBac clearing®

1 US Fl. Oz.
30 mL e

INGREDIENTS AND APPEARANCE

SPECIAL CLEARING BOOSTER 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polysorbate 20 (UNII: 7T1F30V5YH)
Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Chamaemelum Nobile Flower (UNII: O2T154T6OG)
Tilia Cordata Flower (UNII: CFN6G1F6YK)
Centaurea Cyanus Flower (UNII: QZ239038YC)
Chamomile (UNII: FGL3685T2X)
St. John's Wort (UNII: UFH8805FKA)
Nasturtium Officinale Flowering Top (UNII: W1N2U8I64G)
Arctium Lappa Root (UNII: 597E9BI3Z3)
Sage (UNII: 065C5D077J)
Lemon (UNII: 24RS0A988O)
Hedera Helix Leaf (UNII: ZP9XFG71A7)
Saponaria Officinalis Leaf (UNII: 3988313MM7)
Tea Tree Oil (UNII: VIF565UC2G)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Zinc Sulfate (UNII: 89DS0H96TB)
Sulisobenzone (UNII: 1W6L629B4K)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Aminomethylpropanol (UNII: LU49E6626Q)
Butylene Glycol (UNII: 3XUS85K0RA)
Edetate Disodium (UNII: 7FLD91C86K)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-503-02	1 in 1 CARTON
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-503-00	2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/22/2011

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(68479-503)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-503)