PSORIASIS CONTROL by Genuine Virgin Aloe Corporation

Drug Details [pdf]

PSORIASIS CONTROL- salicylic acid cream
Genuine Virgin Aloe 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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ACTIVE INGREDIENT

SALICYLIC ACID 2.5%

PURPOSE:

Psoriasis and seborrheic dermatitis

Uses:

relieves and helps prevent recurrence of:

itching
irritation
redness
flaking
scaling

due to psoriasis and seborrheic dermatitis

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

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

STOP USE AND ASK A DOCTOR IF

condition worsens or does not improve after regular use

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS:

apply generously to affected areas 1 to 4 times daily or as directed by a doctor

Inactive ingredients:

allantoin, aloe barbadensis (AP4® genuine virgin organic aloe vera) leaf extract, avena sativa (oat protein), beeswax, caprylic capric triglyceride, cetearyl alcohol, cetyl alcohol, dimethicone, disodium EDTA, panthenol (pro vitamin B5), petrolatum, phenoxyethanol, polysorbate 60, retinyl palmitate (vitamin A), sodium hyaluronate, sodium PCA, tocopherol acetate (vitamin E), urea, zinc PCA

Other information

store at room temperature
keep carton for important information

Ask a doctor before use if you have psoriasis that covers a large area of the body.

Psoriasis Lotion_carton_42oz

PSORIASIS CONTROL
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OATMEAL (UNII: 8PI54V663Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
ZINC PIDOLATE (UNII: C32PQ86DH4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 10738-101-54	1 in 1 BOX	12/18/2011	08/30/2018
1	NDC: 10738-101-14	119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/18/2011	08/30/2018

Labeler - Genuine Virgin Aloe Corporation (961374147)

Registrant - Genuine Virgin Aloe Corporation (961374147)

Name	Address	ID/FEI	Business Operations
Establishment
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-101)

Revised: 2/2020

Document Id: 586e00bd-63f3-4beb-870b-42c46807a7b1

Set id: 85da1181-6f99-4375-88ae-41e17e0e522b

Version: 8

Effective Time: 20200227

Trademark Results [PSORIASIS CONTROL]

Mark Image Registration \| Serial	Company Trademark Application Date
PSORIASIS CONTROL 86337840 4673292 Live/Registered	GENUINE VIRGIN ALOE CORPORATION 2014-07-15