MEDICATED GEL CLEANSER -2% SALICYLIC ACID- salicylic acid soap

Medicated Gel Cleanser -2% Salicylic Acid by

Drug Labeling and Warnings

Medicated Gel Cleanser -2% Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Only Yourx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid (2%)

INACTIVE INGREDIENT

Other Ingredients: Cocamidopropyl Hydrosultaine (Scherctaine SCAB), Disodium EDTA, D-Panthenol, Deionized Water, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Eucalyptus Oil, Sage Extract, Witch Hazel, Willow Bark, Glycerin, Isoceteth-20, Phenoxyethanol, Pinus Sylvestre, Potassium Sorbate, Sodium Lauryl Sulfoacetate, Water, Xanthan Gum

DOSAGE & ADMINISTRATION

Recommended Use: Use daily both morning and night. Cleanse facial and neck area by massaging a liberal amount onto damp skin using upward circular motions. Rinse thoroughly with warm water.

INDICATIONS & USAGE

To cleanse skin and prevent acne

WARNINGS

WARNING: For External Use Only

KEEP OUT OF REACH OF CHILDREN

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

WHEN USING

When using this product: using other acne medications at the same time may cause excessive dryness or irritation. Do not use in or near eyes, lips and mouth.

PURPOSE

Purpose: acne medication

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDICATED GEL CLEANSER -2% SALICYLIC ACID 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DEXPANTHENOL (UNII: 1O6C93RI7Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SAGE OIL (UNII: U27K0H1H2O)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
WITCH HAZEL (UNII: 101I4J0U34)
WILLOW BARK (UNII: S883J9JDYX)
GLYCERIN (UNII: PDC6A3C0OX)
ISOCETETH-20 (UNII: O020065R7Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-008-45	45 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-008-77	228 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/26/2014

Labeler - Only Yourx, Inc. (089207519)