Country: United States
Language: English
Source: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
ZO Skin Health, Inc.
Salicylic Acid
Salicylic Acid 20 mg in 1 mL
OTC DRUG
Acne Treatment - For the management of acne. - Penetrates pores to control acne blemishes.
OTC monograph final
ZO SKIN HEALTH SKIN NORMALIZING SYSTEM THERAPEUTIC TREATMENT FOR RED, SENSITIZED SKIN- SALICYLIC ACID ZO SKIN HEALTH, INC. _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._ ---------- ZO SKIN HEALTH SKIN NORMALIZING SYSTEM THERAPEUTIC TREATMENT FOR RED, SENSITIZED SKIN NATIONAL DRUG CODE 42851-111-60 _DRUG FACTS_ ACTIVE INGREDIENT Salicylic Acid 2.0% PURPOSE Acne Treatment USES For the management of acne. Penetrates pores to control acne blemishes. WARNINGS FLAMMABLE. KEEP AWAY FROM HEAT AND OPEN FLAME. FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. STOP USE AND ASK A DOCTOR IF If skin irritation occurs or gets worse. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then ® gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. OTHER INFORMATION Read the directions and warnings before use. Store at 15–30°C (59–89°F), away from direct sunlight. INACTIVE INGREDIENTS Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spirae Read the complete document