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NDC 63736-0302-24 Dermarest 3 g/100mL Details

Dermarest 3 g/100mL

Dermarest is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals 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: 63736-0302-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	63736-0302
Product ID	63736-302_f3cbbb8e-5906-4086-ad8e-1a5e2afcce4a
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	Dermarest
Proprietary Name Suffix	Psoriasis Medicated
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	g/100mL
Substance Name	SALICYLIC ACID
Labeler Name	Insight Pharmaceuticals LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63736-0302-24 (63736030224)

Pricing Information	N/A
NDC Package Code	63736-302-24
Billing NDC	63736030224
Package	1 BOTTLE in 1 CARTON (63736-302-24) / 236 mL in 1 BOTTLE
Marketing Start Date	2010-07-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c6a64946-bafd-449f-90cc-e2f6201285f3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 3%

Purposes

Psoriasis and seborrhheic dermatitis treatment

Uses

relieves and helps prevent recurrence of scalp:

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

Stop use and ask a doctor if

condition worsens or does not improve after regular use as directed

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

for best results use at least twice a week or as directed by a doctor
wet hair thoroughly
massage liberal amount of product into scalp
leave lather on for several minutes
rinse thoroughly and repeat if needed

Other information

Store at 15° - 25°C (59° – 77°F)

Inactive ingredients

Purified water, ammonium lauryl sulfate, sodium laureth sulfate, sodium citrate, cocamidopropyl betaine, lauryl glucoside, PEG-150 pentaerythrityl tetrastearate, coco-glucoside, glyceryl oleate, aleurites moluccana seed oil, zinc PCA, panthenol, rheum palmatum extract, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, edetate disodium

Questions?

call 1-800-344-7239 dermarest.com

PRINCIPAL DISPLAY PANEL

- 236 ml Bottle Carton

Dermares®

Psoriasis

Salicylic Acid 3%

Psoriasis & Seborrheic Dermatitis Shampoo

Medicated Shampoo + Conditioner

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

DERMAREST PSORIASIS MEDICATED

salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-302
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ZINC PIDOLATE (UNII: C32PQ86DH4)
PANTHENOL (UNII: WV9CM0O67Z)
RHEUM PALMATUM WHOLE (UNII: 75P857ARCY)
SAFFLOWER (UNII: 4VBL71TY4Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	WHITE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63736-302-24	1 in 1 CARTON	07/23/2010
1		236 mL in 1 BOTTLE; 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	07/23/2010

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020

Document Id: f3cbbb8e-5906-4086-ad8e-1a5e2afcce4a

Set id: c6a64946-bafd-449f-90cc-e2f6201285f3

Version: 4

Effective Time: 20200110