Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Major Pharmaceuticals
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 MAJOR PHARMACEUTICALS _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._ ---------- MAJOR 063.001 063AA ACTIVE INGREDENTS 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 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 59⁰ - 86⁰ F INACTIVE INGREDIENTS bentonite magma, calcium hydroxide, glycerin, purified water QUESTIONS OR COMMENTS? (800) 616-2471 ADVERSE REACTIONS Distributed By: MAJOR PHARMACEUTICALS 17177 N LAUREL PARK DRIVE, SUITE 233 Livonia, MI 48152 Re-Order No 014282 M-97 Rev. 10/16 PRINCIPAL DISPLAY PANEL NDC 0904-2533-21 MAJOR Calamine Lotion Calamine Topical Suspension USP Skin Protectant Poison Ivy, Oak, Sumac Drying Lotion Shake well before using 6 FL OZ (177 mL) CALAMINE ferric oxide red lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:0904-2533 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 8 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH BENTONITE (UNII: A3N5ZCN45C) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Major Pharmaceuticals PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0904- 2533-21 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Lire le document complet