Country: United States
Language: English
Source: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Insight Pharmaceuticals LLC
TOPICAL
OTC DRUG
Psoriasis and seborrheic dermatitis treatment relieves and helps prevent recurrence of scalp: - itching - irritation - redness - flaking - scaling due to psoriasis and seborrheic dermatitis
OTC monograph final
DERMAREST PSORIASIS MEDICATED SCALP TREATMENT- SALICYLIC ACID GEL INSIGHT PHARMACEUTICALS LLC _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._ ---------- DERMAREST PSORIASIS MEDICATED SKIN TREATMENT GEL _DRUG FACTS_ ACTIVE INGREDIENT Salicylic acid 3% PURPOS ES Psoriasis and seborrheic dermatitis treatment US ES 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 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 apply to affected areas one to four times daily or as directed by a doctor OTHER INFORMATION OTHER INFORMATION Store at room temperature 15°-25°C (59°-77°F). INACTIVE INGREDIENTS propylene glycol, purified water, SD alcohol 40, PPG-2 myristyl ether propionate, corn starch modified, zinc PCA, panthenol, aleurites moluccana seed oil, rheum palmatum extract, carthamus tinctorius (safflower) lower extract, camellia sinensis leaf extract, PPG-5-ceteth-20, edetate disodium, xanthan gum, triethanolamine, methylparaben, propylparaben, fragrance QUESTIONS? 1-800-344-7239 DERMAREST.COM PRINCIPAL DISPLAY PANEL DERMAREST PSORIASIS SALICYLIC ACID 3% Psoriasis & Seborrheic Dermatitis Gel MAX STRENGTH MEDICATED GEL 4 FL OZ (118 mL) ® DERMAREST PSORIASIS MEDICATED SCALP TREATMENT salicylic acid gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 3736 -312 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRE Read the complete document