ALA-SEPTIC- salicyclic acid cream 
Ala-Septic Pharmaceutical Research LLC

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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Ala-Septic

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.

image description

ALA-SEPTIC 
salicyclic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59434-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59434-001-04100 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/01/2013
Labeler - Ala-Septic Pharmaceutical Research LLC (964652692)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(59434-001)

Revised: 12/2013
Document Id: 503ef007-a5ac-4abc-90b1-b13bd0a05d08
Set id: edb70750-bea8-4c0f-9453-f2c38d2f05d9
Version: 1
Effective Time: 20131216
 
Ala-Septic Pharmaceutical Research LLC