Drug Facts

Active Ingredients

Salicylic Acid 2.00%

Purpose

Seborrheic Dermatitis, Psoriasis

Use For:

For relief of the symptoms of seborrheic dermatitis and psoriasis.

Warning:

For external use only.

When using this product

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Ask a doctor before using this product if

condition covers a large area of the body

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Apply to affected areas one to four times daily or as directed by a doctor.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzoic Acid, Butylene Glycol, C13-14 Isoparaffin, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Iodoquinol, Isopropyl Myristate, Larrea Tridentata Extract, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Phenoxyethanol, Polyacrylamide, Polysorbate-20, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin-E).

Package Labeling:

Bottle Label

ALA-SEPTIC
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59434-134
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
IODOQUINOL (UNII: 63W7IE88K8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
LAURETH-7 (UNII: Z95S6G8201)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59434-134-00	113 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M032	03/01/2021

Labeler - Ala-Septic Pharmaceutical Research LLC (964652692)

ALA-SEPTIC Lotion