País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Cosette Pharmaceuticals, Inc.
Dimethicone
Dimethicone 20 mg in 1 g
TOPICAL
OTC DRUG
Skin Protectant • helps treat and prevent rash associated with the use of absorbent products for adult incontinence • protects minor skin irritation due to inflammatory skin conditions and helps seal out wetness
OTC monograph final
CARLESTA - DIMETHICONE, ZINC OXIDE OINTMENT COSETTE PHARMACEUTICALS, 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._ ---------- CARLESTA® OINTMENT ACTIVE INGREDIENT Dimethicone 2% Zinc Oxide 26% PURPOSE Skin Protectant USES • helps treat and prevent rash associated with the use of absorbent products for adult incontinence • protects minor skin irritation due to inflammatory skin conditions and helps seal out wetness WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT • avoid contact with the eyes STOP USE AND ASK A DOCTOR IF • condition worsens or does not improve within 7 days KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS • apply liberally as often as necessary especially at bedtime or any time when exposure to soiled absorbent products may be prolonged OTHER INFORMATION • store at room temperature INACTIVE INGREDIENT butylated hydroxytoluene, cod liver oil, glyceryl monostearate, lanolin, methylparaben, mineral oil, mono- and diglyceride, polysorbate 40, propylparaben, purified water, starch, tea tree oil, white petrolatum PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0713-0623-32 Carlesta® A D U L T S K I N P R O T E C T A N T Net Wt. 4 oz (114 g) - Formulated especially for adults - Protection barrier from wetness - Soothes chafed and irritated skin resulting from adult incontinence CARLESTA dimethicone, zinc oxide ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 713-0 6 23 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O) DIMETHICONE 20 mg in 1 g ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 26 0 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH PETRO LATUM (UNII: 4T6 H Llegiu el document complet