Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Calamine 8% and Zinc Oxide 8%
Pharma Nobis, LLC
TOPICAL
OTC DRUG
Dries the oozing and weeping of poison ivy, poison oak, and poison sumac. Skin protectant condition worsens, does not improve or if symptoms last more than 7 days, or clear up and occur again within a few days.
OTC monograph final
CALAMINE- CALAMINE AND ZINC OXIDE LOTION PHARMA NOBIS, LLC ---------- FRESKARO CALAMINE LOTION Drug Facts ACTIVE INGREDIENTS Calamine 8% and Zinc Oxide 8% USES Dries the oozing and weeping of poison ivy, poison oak, and poison sumac. PURPOSE Skin protectant WARNINGS For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on chilren under 2 years of age. STOP USE AND ASK A DOCTOR IF condition worsens, does not improve or if symptoms last more than 7 days, or clear up and occur again within a few days. KEEP OUT OF REACH OF CHILDREN In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away. DIRECTIONS 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, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Consult a doctor before use OTHER INFORMATION Store at room temperature 15-30C (59-86F) INACTIVE INGREDIENTS Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum QUESTIONS Questions or Comments? 1-833-551-0932 LABEL CALAMINE calamine and zinc oxide lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:82645-418 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 CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 mL INACTIVE INGREDIENTS Pharma Nobis, LLC INGREDIENT NAME STRENGTH BENTONITE (UNII: A3N5ZCN45C) CARRAGEENAN (UNII: 5C69YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE M Baca dokumen lengkapnya