País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Calamine 8% Zinc oxide 8%
Dolgencorp, LLC
FERRIC OXIDE RED
FERRIC OXIDE RED .8 kg in 100 L
TOPICAL
OTC DRUG
skin protectant dries the oozing and weeping of poison:•ivy • oak • sumac - condition worsens - symptoms last more than 7 days or clear up and occur again wthin a few days
OTC monograph final
CALAMINE - FERRIC OXIDE RED LOTION DOLGENCORP, 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._ ---------- REXALL 063.001 063AA ACTIVE INGREDIENTS Calamine 8% Zinc oxide 8% PURPOSE skin protectant USE dries the oozing and weeping of poison:•ivy • oak • sumac WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT do not get into eyes STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again wthin a few days KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away DIRECTIONS • shake well before using • apply as needed OTHER INFORMATION store at 59⁰ - 86⁰ F INACTIVE INGREDIENTS bentonite magma, calcium hydroxide, glycerin, purified water Visit us at: Rexall.com or call 1-866-4REXALL DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 USA PRINCIPAL DISPLAY PANEL Since 1903 REXALL Calamine Lotion Calamine Topical Suspension USP • Poison ivy, oak and sumac drying lotion • Skin protectant 6 FL OZ (177 mL) CALAMINE ferric oxide red lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:55910-063 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 80 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 80 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH BENTONITE (UNII: A3N5ZCN45C) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:55910- 063-30 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/13/2009 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATIO Leia o documento completo