ALA-SEPTIC- salicyclic acid cream

Ala-Septic by

Drug Labeling and Warnings

Ala-Septic by is a Otc medication manufactured, distributed, or labeled by Ala-Septic Pharmaceutical Research LLC, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

warnings

For external use only.

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

Do not use without consulting a doctor if the condition appears over a large portion of hte body.

If condition worsens, or does not improve after using as directed, consult physician.

Do not use for prolonged periods without consulting a docotor.

Active ingredient

Salicylic Acid 2.00%

Purpose

Dermatitis Treatment

Use for:

For relief of itching, irritation, redness and scaling assoicated with psoriasis, eczema and seborrheic dermatitis.

Other ingredients:

Aloe Barbadensis Leaf Juice, Aqua (deionized water), benzoic acid, butylene glycol, C13-14 isoparaffin, ethylhexylglycerin, glycrrhiza glabra (licorice) extract, iodoquinol, isoproply myristate, larrea tridentata extract, larueth-7, melaleuca alternifolia (tea tree) oil, phenoxyethanol, polyacrylamide, polysorbate-20, SD-alcohocl 40B, tocopheryl acetate (vitamin E).

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Directions:

Wash affected areas well with soap and water. Pat dry. Apply cream to affected area one to four times per day, or as directed by physician.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALA-SEPTIC 
salicyclic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59434-001
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
water (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LICORICE (UNII: 61ZBX54883)
IODOQUINOL (UNII: 63W7IE88K8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LARREA TRIDENTATA WHOLE (UNII: B755J144H1)
LAURETH-7 (UNII: Z95S6G8201)
TEA TREE OIL (UNII: VIF565UC2G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59434-001-04	100 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/01/2013

Labeler - Ala-Septic Pharmaceutical Research LLC (964652692)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture(59434-001)