PSORIASIS CONTROL- salicylic acid gel

PSORIASIS CONTROL by

Drug Labeling and Warnings

PSORIASIS CONTROL by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation, FMK Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active ingredient

Salicylic acid 3.0%

Purpose

Control of Psoriasis, Dermatitis

INDICATIONS & USAGE

Uses relieves and helps prevent recurrence of: itching irritation redness flaking scaling due to psoriasis and seborrheic dermatitis

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions Use at least twice a week or as directed by a doctor. Wet hair, apply and massage into scalp.
Leave on for several minutes. Rinse thoroughly.

INACTIVE INGREDIENT

Inactive ingredients: water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, urea, glycol distearate, polyquaternium-7, colloidal oatmeal / avena sativa (oat) kernel flour, aloe barbadensis leaf juice*, oenothera biennis (evening primrose) oil, helianthus annuus (sunflower) seed oil, glycerin, glycyrrhiza glabra (licorice) root extract, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), allantoin, zinc PCA, piroctone olamine, PEG-150 distearate, sodium citrate, acrylates crosspolymer-4, PEG-12, methyl glucose trioleate, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

Questions? 1-800-279-7282 M-F 8am-4pm PST

SPL UNCLASSIFIED SECTION

Relieves and helps prevent recurrence of itching, flaking & scaling

AP4 BOTANICAL

ALOE VERA COMPLEX

SALICYLIC ACID

Psoriasis & Seborrheic Dermatitis

EXPERTS IN SKIN HEALING SINCE 1992

Psoriasis Control® Shampoo contains clinically proven ingredients that help soothe and relieve psoriasis symptoms.

Gentle on hair
Relieves dry, itchy scalp & flaking
Leaves hair silky soft

NO Steroids, Coal Tar or Cortisone Paraben & SLS Free

www.triderma.com

MADE IN THE USA

Dist. by: Genuine Virgin Aloe Corp.

Corona, CA 92879

Packaging

INGREDIENTS AND APPEARANCE

PSORIASIS CONTROL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
(1,1-DIMETHYLETHYL)UREA (UNII: T81TP489AF)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
OATMEAL (UNII: 8PI54V663Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-098-23	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/01/2016

Labeler - Genuine Virgin Aloe Corporation (961374147)

Registrant - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-098)