Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Hy-Vee, Inc
FERRIC OXIDE RED
FERRIC OXIDE RED 8 g in 1 mL
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 within a few days
OTC monograph final
CALAMINE - FERRIC OXIDE RED LOTION HY-VEE, 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._ ---------- DRUG FACTS ACTIVE INGREDENTS Calamine 8% Zinc oxide 8% PURPOS E Skin Protectant US E 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 within 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 59 - 86 F INACTIVE INGREDIENTS bentonite magma, calcium hydroxide, glycerin, purified water ADVERSE REACTION SECTION DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 SATISFACTION GUARANTEED OR PURCHASE PRICE REFUNDED FOR INFORMATION CALL 1-800-289-8343 www.hy-vee.com 063.001/063AA PRINCIPAL DISPLAY PANEL HY-VEE Calamine Lotion Calamine topical suspension USP skin protectant Poison Ivy, Oak, Sumac Drying Lotion 6 FL OZ (177mL) CALAMINE ferric oxide red lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:4250 7-0 6 3 ROUTE OF ADMINISTRATION TOPICAL Hy-Vee, Inc ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75) (FERRIC OXIDE RED - UNII:1K0 9 F3G6 75) FERRIC OXIDE RED 8 g in 1 mL ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH BENTO NITE (UNII: A3N5ZCN45C) CALCIUM HYDRO XIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:4250 7-0 6 3- 30 177 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duc Baca dokumen lengkap