Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
TOPCO ASSOCIATES LLC
TOPICAL
OTC DRUG
Skin protectant dries the oozing and weeping o poison ivy, poison oak, and poison sumac.
OTC monograph final
TOPCARE CALAMINE- CALAMINE 8% AND ZINC OXIDE 8% LOTION LOTION TOPCO ASSOCIATES LLC ---------- TOP CARE CALAMINE LOTION Calamine 8% and Zinc Oxide 8% Skin protectant dries the oozing and weeping o poison ivy, poison oak, and poison sumac. For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on chilren 2 years of age. In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately. Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort. Children under 2 years of age: Consult a doctor before use. Bentonite magma, calcium hydroxide, glycerin, purified water. TOPCARE CALAMINE calamine 8% and zinc oxide 8% lotion lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:36800-702 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 160 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH TOPCO ASSOCIATES LLC BENTONITE (UNII: A3N5ZCN45C) CARRAGEENAN (UNII: 5C69YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) GLYCERIN (UNII: PDC6A3C0OX) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:36800- 702-96 177 mL in 1 CONTAINER; Type 0: Not a Combination Product 07/16/2019 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M016 07/16/2019 LABELER - TOPCO ASSOCIATES LLC (006935977) REGISTRANT - Pharma Nobis, LLC (118564114) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Pharma Nobis, LLC 118564114 analysis(36800-702) , manufacture(36800-702) , label(36800-702) , pack(3 Lesen Sie das vollständige Dokument