OIL CONTROL- salicylic acid lotion 
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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Oil Control Lotion

Drug Facts

Active ingredient

Salicylic Acid (1.0%)

Indications

  • For the treatment of acne.

Warnings

For external use only.

Do not use

  • Do not use around eye area.
  • If contact occurs, flush thoroughly with water.
  • If irritation develops, discontinue use. Consult a doctor if irritation persists.

When using this product

  • If dryness or irritation occurs when using other topical acne products at the same time, limit usage to one acne product.

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

Directions

Inactive ingredients

Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Isododecane, Potato Starch Modified, Silica, Hyssopus Officinalis Extract, Melissa Officinalis Leaf Extract, Echinacea Purpurea Extract, Enantia Chlorantha Bark Extract, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Salix Nigra (Willow) Bark Extract, Allantoin, Panthenol, Sodium PCA, Bisabolol, Niacinamide, Ammonium Glycyrrhizate, Zinc Gluconate, Caffeine, Biotin, Phospholipids, Magnesium Ascorbyl Phosphate, Camphor, Menthol, Hamamelis Virginiana (Witch Hazel) Water, Oleanolic Acid, Sodium Hydroxide, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Xanthan Gum, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Nylon-12, Glycerin, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

oil
control
lotion

dermalogica®

mediBac clearing®

2 US FL OZ
60 mL e

Principal Display Panel - 60 mL Bottle Carton
OIL CONTROL 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Isododecane (UNII: A8289P68Y2)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hyssopus Officinalis Flowering Top (UNII: X7HKN4FOJI)  
Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
Echinacea Purpurea (UNII: QI7G114Y98)  
Annickia Chlorantha Bark (UNII: H70115MP4A)  
Yeast, Unspecified (UNII: 3NY3SM6B8U)  
Horse Chestnut (UNII: 3C18L6RJAZ)  
Allantoin (UNII: 344S277G0Z)  
Panthenol (UNII: WV9CM0O67Z)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Levomenol (UNII: 24WE03BX2T)  
Omega-3 Fatty Acids (UNII: 71M78END5S)  
Niacinamide (UNII: 25X51I8RD4)  
Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
Zinc Gluconate (UNII: U6WSN5SQ1Z)  
Caffeine (UNII: 3G6A5W338E)  
Biotin (UNII: 6SO6U10H04)  
Oleanolic Acid (UNII: 6SMK8R7TGJ)  
Salix Nigra Bark (UNII: QU52J3A5B3)  
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Xanthan Gum (UNII: TTV12P4NEE)  
Nylon-12 (UNII: 446U8J075B)  
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-808-021 in 1 CARTON
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68479-808-0122 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68479-808-04177 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68479-808-002 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H12/04/2003
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway620899877MANUFACTURE(68479-808)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-808)

Revised: 11/2015
Document Id: 9be73424-6777-43b6-b8e1-ab0e425bf3dd
Set id: b0c02c45-efa6-4ad6-992c-8bd8f1c43516
Version: 2
Effective Time: 20151120
 
Dermalogica, Inc.