MEDIBAC CLEARING COMPLEX- salicylic acid liquid

MediBac Clearing Complex by

Drug Labeling and Warnings

MediBac Clearing Complex by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid (0.5%)

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

When using this product, using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a physician.

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

Do not use around eye area. If contact occurs, flush thoroughly with water. If irritation develops, discontinue use.

Directions

• Press 6 to 10 drops into skin before applying recommended Dermalogica Moisturizer.

Inactive ingredients

Water (Aqua), Butylene Glycol, Ethoxydiglycol, PPG-2 Isoceteth-20 Acetate, Nordihydroguaiaretic Acid, Niacinamide, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Symphytum Officinale Leaf Extract, Panthenol, Ammonium Glycyrrhizate, Zinc Gluconate, Caffeine, Biotin, Camphor, PEG-60 Almond Glycerides, Perfluorononylethyl Carboxydecyl PEG-10 Dimethicone, 10-Hydroxydecanoic Acid, Sebacic Acid, Oleanolic Acid, 1,10-Decanediol, Chlorphenesin, Caprylyl Glycol, Propylene Glycol, Simethicone, Glycerin, Carbomer, Aminomethyl Propanol, Phenoxyethanol.

Questions?

1-800-831-5150 (USA) Monday–Friday 9AM PST to 5PM PST

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

dermalogica®
professional

mediBac clearing™
complex

acne treatment

Recommended for acneic
and breakout-prone skin.

A lightweight, medicated
treatment that penetrates
deeply to clear congested
follicles, regulate sebum
production and eliminate
bacteria to promote skin clarity
well beyond the professional
skin treatment.

directions:

1. Press 6 to 10 drops into skin
before applying recommended
Dermalogica Moisturizer.

mediBac clearing™

1 FL OZ / 30 ml e

Dermalogica, Dist.
Los Angeles, CA 90009 USA
1-800-831-5150
Europe: London KT22 7TW UK

INGREDIENTS AND APPEARANCE

MEDIBAC CLEARING COMPLEX 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
PPG-2 Isoceteth-20 Acetate (UNII: BI6C7YO419)
Masoprocol (UNII: 7BO8G1BYQU)
Niacinamide (UNII: 25X51I8RD4)
Yeast, unspecified (UNII: 3NY3SM6B8U)
Horse Chestnut (UNII: 3C18L6RJAZ)
Panthenol (UNII: WV9CM0O67Z)
Ammonium Glycyrrhizate (UNII: 3VRD35U26C)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Caffeine (UNII: 3G6A5W338E)
Biotin (UNII: 6SO6U10H04)
Comfrey Leaf (UNII: DG4F8T839X)
Camphor (Synthetic) (UNII: 5TJD82A1ET)
PEG-60 Almond Glycerides (UNII: 4Y0E651N0F)
10-Hydroxydecanoic Acid (UNII: NP03XO416B)
Sebacic Acid (UNII: 97AN39ICTC)
Oleanolic Acid (UNII: 6SMK8R7TGJ)
1,10-Decanediol (UNII: 5I577UDK52)
Chlorphenesin (UNII: I670DAL4SZ)
Caprylyl Glycol (UNII: 00YIU5438U)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Aminomethylpropanol (UNII: LU49E6626Q)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-804-02	1 in 1 CARTON
1		30 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
OTC MONOGRAPH FINAL	part358H	05/09/2007

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(68479-804)