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NDC 70656-0740-01 DuSel Psoriasis Dead Sea Salt Therapy 20 mg/mL Details

DuSel Psoriasis Dead Sea Salt Therapy 20 mg/mL

DuSel Psoriasis Dead Sea Salt Therapy is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Nanovita One LLC. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 70656-0740-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	70656-0740
Product ID	70656-740_47f4d4c4-fb0d-5e0e-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DuSel Psoriasis Dead Sea Salt Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	SALICYLIC ACID
Labeler Name	Nanovita One LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70656-0740-01 (70656074001)

Pricing Information	N/A
NDC Package Code	70656-740-01
Billing NDC	70656074001
Package	5 mL in 1 PACKET (70656-740-01)
Marketing Start Date	2016-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7be4b782-e4cd-4e7b-b61e-bc23080fe119 Details

Drug Facts:

Active Ingredient:

Salicylic Acid 2.00%

Psoriasis treatment

Uses:

For relief or controls the symptoms of psoriasis.

Warnings:

For external use only

Do not use

if you have very sensitive skin or are sensitive to Salicylic Acid

When using this product

Avoid contact with eyes. If this happens, rinse thoroughly with water.
If conditions worsens or does not improve after regular use of this product as directed, consult a physician.
Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
If condition covers a large area of the body, consult your physician before using this product. Stop and ask a doctor if irritation becomes

Stop and ask a doctor if

irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cleanse the skin thoroughly before applying medication
Cover the entire affected area with athin layer one to three times a day.Because excessive drying of the skinmay occur, start with one applicationdaily, then gradually increase to 2 to 3times daily if needed or as directed bya doctor. If bothersome dryness orpeeling occurs, reduce application toonce a day or every other day.

Inactive ingredients:

Aqua (Deionized Water), Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Isopropyl

Myristate, Laureth-7, Maris Sal (Dead Sea) Salt, Phenoxyethanol, Polyacrylamide, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

INGREDIENTS AND APPEARANCE

DUSEL PSORIASIS DEAD SEA SALT THERAPY

salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70656-740
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70656-740-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	04/26/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	04/26/2016

Labeler - Nanovita One LLC (080217774)

Revised: 2/2017

Document Id: 47f4d4c4-fb0d-5e0e-e054-00144ff8d46c

Set id: 7be4b782-e4cd-4e7b-b61e-bc23080fe119

Version: 3

Effective Time: 20170207