PSORIASIS CONTROL- salicylic acid gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Genuine Virgin Aloe Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Control of Psoriasis, Dermatitis Uses  relieves and helps prevent recurrence of: •itching •irritation •redness •flaking •scaling due to psoriasis and seborrheic dermatitis
Authorization status:
OTC monograph final
Authorization number:
10738-098-23

PSORIASIS CONTROL- salicylic acid gel

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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TRIDERMA Psoriasis Control SHAMPOO

Drug Facts

Active ingredient

Salicylic acid 3.0%

Purpose

Control of Psoriasis, Dermatitis

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

psoriasis and seborrheic dermatitis

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.

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

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

PSORIASIS CONTROL

salicylic acid gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 738 -0 9 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

3 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

®

Genuine Virgin Aloe Corporation

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

( 1,1-DIMETHYLETHYL) UREA (UNII: T8 1TP48 9 AF)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

PO LYQ UATERNIUM-7 ( 7 0 /3 0 ACRYLAMIDE/DADMAC; 16 0 0 0 0 0 MW) (UNII: 0 L414VCS5Y)

O ATMEAL (UNII: 8 PI54V6 6 3Y)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

EVENING PRIMRO SE O IL (UNII: 3Q9 L0 8 K71N)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

PANTHENO L (UNII: WV9 CM0 O6 7Z)

ALLANTO IN (UNII: 344S277G0 Z)

ZINC PIDO LATE (UNII: C32PQ8 6 DH4)

PIRO CTO NE O LAMINE (UNII: A4V5C6 R9 FB)

PEG-150 DISTEARATE (UNII: 6 F36 Q0 I0 AC)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID CO PO LYMER ( 18 0 0 0 MW) (UNII:

JZ1374NL9 E)

PO LYETHYLENE GLYCO L 6 0 0 (UNII: NL4J9 F21N9 )

METHYL GLUCO SE DIO LEATE (UNII: FA9 KFJ4Z6 P)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:10 738 -0 9 8 -

245 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /30 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 8 /0 1/20 16

Labeler -

Genuine Virgin Aloe Corporation (961374147)

Registrant -

Genuine Virgin Aloe Corporation (961374147)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Genuine Virgin Alo e Co rpo ratio n

9 6 1374147

ma nufa c ture (10 738 -0 9 8 )

Revised: 10/2019

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