DERMASOLVE MEDICATED- salicylic acid soap

DermaSolve Medicated by

Drug Labeling and Warnings

DermaSolve Medicated by is a Otc medication manufactured, distributed, or labeled by Fortitude Health, LLC, Stream2Sea LLC, Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 3%

PURPOSE

Psoriasis/Seborrheic Dermatitis/Dandruff

INDICATIONS & USAGE

Controls the symptoms associated with Psoriasis, Seborrheic Dermatitis and/or Dandruff including itching, scaling, flaking, redness, and irritation.

WARNINGS

For external use only.

Ask a doctor before use if you have a condition that covers a large are of the body.

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

For best results use at least twice a week or as directed by a doctor.

• Use on affected areas in place of your regular soap
• Apply onto moistened skin
• Allow later to remain on skin for several minutes
• Rinse thoroughly with warm water and pat dry. For best results use at least twice a week or as directed by a doctor.
• A patch test should be done prior to use if you are concerned about any ingredients.
• This is a low foam shampoo.
• Can be used daily

INACTIVE INGREDIENT

Deionized Water, Sodium Laryl Ether Sulfate, Coamidopropyl Betaine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Ethylene Glycol Monostearate, Egg Powder, Aloe Barbadensis Leaf Juice, Polyquaternium-7, Citrus Paradisi (Grapefruit) Seed Oil, Propylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Triethanolamine, Disodium EDTA.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMASOLVE MEDICATED 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84285-102
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 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-20 (UNII: YRC528SWUY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIETHYLENE GLYCOL MONOSTEARATE (UNII: TWG3GKC3M9)
EGG (UNII: 291P45F896)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)
POLYQUATERNIUM-7 (UNII: 0L414VCS5Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84285-102-08	226 g in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	10/21/2024

Labeler - Fortitude Health, LLC (064309530)

Registrant - Stream2Sea LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(84285-102)