PSORIASIS CONTROL- salicylic acid cream

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:
Psoriasis and seborrheic dermatitis relieves and helps prevent recurrence of: - itching - irritation - redness - flaking - scaling due to psoriasis and seborrheic dermatitis STOP USE AND ASK A DOCTOR IF - condition worsens or does not improve after regular use
Authorization status:
OTC monograph final
Authorization number:
10738-101-14, 10738-101-54

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

Us es :

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 CONTROL

salicylic acid cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 738 -10 1

Route of Administration

TOPICAL

Genuine Virgin Aloe Corporation

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

SALICYLIC ACID

2.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALLANTO IN (UNII: 344S277G0 Z)

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

O ATMEAL (UNII: 8 PI54V6 6 3Y)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

PETRO LATUM (UNII: 4T6 H12BN9 U)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

UREA (UNII: 8 W8 T178 47W)

ZINC PIDO LATE (UNII: C32PQ8 6 DH4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 738 -10 1-54

1 in 1 BOX

12/18 /20 11

1

NDC:10 738 -10 1-14

119 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

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

12/18 /20 11

Labeler -

Genuine Virgin Aloe Corporation (743159706)

Registrant -

Genuine Virgin Aloe Corporation (743159706)

Revised: 5/2019

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