País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Denison Pharmaceuticals, LLC
TOPICAL
OTC DRUG
For the treatment of acne For the treatment of acne
OTC monograph final
ZAPZYT ACNE WASH CLEANSER- SALICYLIC ACID GEL DENISON 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._ ---------- ZAPZYT ACNE WASH CLEANSER For the treatment of acne Salicylic Acid 2% _USES_ For the treatment of acne _WARNINGS_ FOR EXTERNAL USE ONLY. avoid contact with the eyes. If contact occurs, flush thoroughly with water. using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of skin. If this occurs, only one medication should be used unless directed by a doctor. _DIRECTIONS_ Use daily Add water Apply to hands Massage gently to the affected area Rinse thoroughly _OTHER INFORMATION_ Store at room temperature 15 - 30 C (59 - 86 F) _INACTIVE INGREDIENTS_ Purified water, Disodium EDTA, Chamomile Extract, Aloe Vera Gel, Bioterge AS-40, Cocamidopropyl Betaine, Glucamate DOE-120, Glydant, Sodium Chloride KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away PRINCIPAL DISPLAY PANEL 0 0 0 0 Denison Pharmaceuticals, LLC ZAPZYT ACNE WASH CLEANSER salicylic acid gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 29 5-0 0 71 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U) PEG-12 0 METHYL GLUCO SE DIO LEATE (UNII: YM0 K6 4F20 V) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) WATER (UNII: 0 59 QF0 KO0 R) CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX) CHAMO MILE (UNII: FGL36 8 5T2X) EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) DMDM HYDANTO IN (UNII: BYR0 546 TOW) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START Leia o documento completo