OIL CONTROL- salicylic acid lotion

Oil Control by

Drug Labeling and Warnings

Oil Control by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Apply to cleansed face and throat twice daily.
• Avoid eye area.

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

INGREDIENTS AND APPEARANCE

OIL CONTROL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-808
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-808-02	1 in 1 CARTON
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-808-01	22 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68479-808-04	177 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 68479-808-00	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	part358H	12/04/2003

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-808)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-808)