OVERNIGHT CLEARING- salicylic acid gel 
Dermalogica, Inc.

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.

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Overnight Clearing Gel

Drug Facts

Active Ingredients

Salicylic Acid 2.0%

Indications

  • For the treatment of acne.

Warnings

For external use only.

Do not use on broken skin or on large areas of the body.

When using this product

  • Apply to affected areas 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.

Avoid unnecessary sun exposure and use a sunscreen.

Do not use in or near eyes.

Stop use and ask a Doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water (Aqua), PEG-32, Butylene Glycol, Salicylic Acid, PVM/MA Decadiene Crosspolymer, Polysorbate 20, Glycerin, PEG-60 Almond Glycerides, Mahonia Aquifolium Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Oleifera Leaf Extract, Spiraea Ulmaria Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Crithmum Maritimum Extract, Yeast Extract, Hydrogenated Vegetable Oil, Sodium Hyaluronate, Biotin, Panthenol, Caffeine, Niacinamide, Dipotassium Glycyrrhizate, Camphor, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Nordihydroquaiaretic Acid, Oleanolic Acid, Xanthan Gum, Carbomer, PEG-40 Hydrogenated Castor Oil, Ammonium Glycyrrhizate, Zinc Gluconate, Zinc Acetate, Sodium Hydroxide, Caprylic/Capric Triglyceride, Chlorphenesin, Caprylyl Glycol, Phenoxyethanol, Limonene, Linalool, Geraniol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cymbopogon Martini Oil, Mentha Piperita (Peppermint) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Mentha Viridis (Spearmint) Leaf Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Artemisia Vulgaris Oil, Litsea Cubeba Fruit Oil, Piper Nigrum (Pepper) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Ocimum Basilicum (Basil) Oil, Cymbopogon Nardus (Citronella) Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

overnight
clearing
gel

acne treatment

mediBac clearing®

1.7 US FL OZ
50 mL e

dermalogica®

Principal Display Panel - 50 mL Bottle Carton
OVERNIGHT CLEARING 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-706
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Polyethylene Glycol 1500 (UNII: 1212Z7S33A)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Glycerin (UNII: PDC6A3C0OX)  
PEG-60 Almond Glycerides (UNII: 4Y0E651N0F)  
BERBERIS AQUIFOLIUM ROOT (UNII: 746TB9VNDP)  
Rosemary (UNII: IJ67X351P9)  
Camellia Oleifera Leaf (UNII: 5077EL0C60)  
Filipendula Ulmaria Root (UNII: 997724QNDS)  
Horse Chestnut (UNII: 3C18L6RJAZ)  
Crithmum Maritimum (UNII: J7IHY79BKY)  
Yeast, Unspecified (UNII: 3NY3SM6B8U)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Biotin (UNII: 6SO6U10H04)  
Panthenol (UNII: WV9CM0O67Z)  
Caffeine (UNII: 3G6A5W338E)  
Niacinamide (UNII: 25X51I8RD4)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
10-Hydroxydecanoic Acid (UNII: NP03XO416B)  
Sebacic Acid (UNII: 97AN39ICTC)  
1,10-Decanediol (UNII: 5I577UDK52)  
Masoprocol (UNII: 7BO8G1BYQU)  
Oleanolic Acid (UNII: 6SMK8R7TGJ)  
Xanthan Gum (UNII: TTV12P4NEE)  
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
Zinc Gluconate (UNII: U6WSN5SQ1Z)  
Zinc Acetate (UNII: FM5526K07A)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Chlorphenesin (UNII: I670DAL4SZ)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Tea Tree Oil (UNII: VIF565UC2G)  
Rosemary Oil (UNII: 8LGU7VM393)  
Palmarosa Oil (UNII: 0J3G3O53ST)  
Peppermint Oil (UNII: AV092KU4JH)  
Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
Lemon Oil (UNII: I9GRO824LL)  
Fennel Oil (UNII: 59AAO5F6HT)  
Spearmint Oil (UNII: C3M81465G5)  
Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Ginger Oil (UNII: SAS9Z1SVUK)  
Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V)  
Litsea Oil (UNII: 2XIW34BN6O)  
White Pepper Oil (UNII: 2AM83DL9FV)  
Nutmeg Oil (UNII: Z1CLM48948)  
Basil Oil (UNII: Z129UMU8LE)  
Citronella Oil (UNII: QYO8Q067D0)  
Cinnamon Bark Oil (UNII: XE54U569EC)  
Orange Oil (UNII: AKN3KSD11B)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Sage Oil (UNII: U27K0H1H2O)  
Thyme Oil (UNII: 2UK410MY6B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-706-021 in 1 CARTON05/01/2007
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68479-706-0114 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2007
3NDC:68479-706-002 mL in 1 POUCH; Type 0: Not a Combination Product05/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/01/2007
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
McKenna090631412MANUFACTURE(68479-706)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-706)

Revised: 12/2017
Document Id: 62468211-f4d7-4ee3-8905-89633321a074
Set id: 6f6d9bd9-a1c8-4f8c-b7b8-fe9748a06c2c
Version: 3
Effective Time: 20171204
 
Dermalogica, Inc.