Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
TOPICAL
OTC DRUG
Skin protectant Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
OTC monograph final
L-TOPICAL CALAMINE 8% ZINC OXIDE 8%- CALAMINE, ZINC OXIDE LOTION GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED _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._ ---------- L-TOPICAL CALAMINE 8% ZINC OXIDE 8% LOTION DRUG FACTS ACTIVE INGREDIENT Calamine 8% and Zinc Oxide 8% PURPOSE Skin protectant INDICATIONS & USAGE Dries the oozing and weeping of poison ivy, poison oak, and poison sumac. WARNINGS • For external use only. Use only as directed. • Avoid contact with eyes and mucous membranes. • Ask a doctor before using on children 6 months of age. KEEP OUT OF REACH OF CHILDREN In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately. DOSAGE & ADMINISTRATION • Adults and children 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry before each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort. • Children under 6 months of age: Consult a doctor before use. INACTIVE INGREDIENT Bentonite magma, Calcium hydroxide, Glycerin, Purified water. OTHER INFORMATION Store at room temperature 15-30°C (59-86°F). QUESTIONS? Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST. _SOOTHING CALAMINE LOTION_ √ POISON IVY√ POISON OAK√ POISON SUMAC Manufactured by : GLOBAL PHARMA HEALTHCARE PVT. LTD., A-9, SIDCO Pharmaceutical Complex, Alathur-603 110 - INDIA. WWW.GLOBAL-PHARMA.COM PACKAGING L-TOPICAL CALAMINE 8% ZINC OXIDE 8% calamine, zinc oxide lotion GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:73921-035 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) Aqra d-dokument sħiħ