Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

DERMALOGICA OIL CONTROL- salicylic acid lotion 
PureTek Corporation

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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Drug Facts

Active ingredient

Salicylic Acid (1.0%)

Purpose

Acne Treatment

Keep out of reach of children.

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

Use

Treats acne

Warnings

For external use only.

Directions

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

Inactive ingredients

Water (Aqua), 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.

Do not use

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

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.

DERMALOGICA OIL CONTROL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-737
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)
STARCH, POTATO (UNII: 8I089SAH3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MELISSA OFFICINALIS (UNII: YF70189L0N)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
YEAST (UNII: 3NY3SM6B8U)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
LEVOMENOL (UNII: 24WE03BX2T)
NIACINAMIDE (UNII: 25X51I8RD4)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
CAFFEINE (UNII: 3G6A5W338E)
BIOTIN (UNII: 6SO6U10H04)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL (UNII: L7T10EIP3A)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-737-05	1 in 1 CARTON	11/17/2003	05/01/2019
1		60 mL in 1 TUBE; 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	11/17/2003	05/01/2019

Labeler - PureTek Corporation (785961046)

Revised: 5/2019

Document Id: a87b55a4-2f71-4449-a351-9c691ea1b704

34390-5

Set id: 63c6bff9-5f4e-421c-b911-e67b052c5359

Version: 3

Effective Time: 20190501