البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
Calamine 7.6% and Zinc Oxide 7.6%
1201258 Ontario Inc. O/A Nanz Pharma
TOPICAL
OTC DRUG
Skin protectant For temporary relief of skin irritations and itching caused by insect bites, sunburn, poison ivy, sumac, and poison oak.
OTC monograph final
CALAMINE- NANZ RELIEVE CALAMINE LOTION LOTION 1201258 ONTARIO INC. O/A NANZ PHARMA _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._ ---------- NANZ RELIEVE CALAMINE LOTION ACTIVE INGREDIENTS Calamine 7.6% and Zinc Oxide 7.6% PURPOSE Skin protectant USES: For temporary relief of skin irritations and itching caused by insect bites, sunburn, poison ivy, sumac, and poison oak. CAUTION & WARNINGS: For external use only.Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if symptoms worsen or last for more than 7 days.When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not use on broken skin. KEEP OUT OF REACH OF CHILDREN In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately. 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, as often as needed for comfort. Children under 6 months of age: Consult a doctor before use. INACTIVE INGREDIENTS Glycerin, Bentonite, Calcium Hydroxide, Water OTHER INFORMATION: Store at room temperature 13-30C (50-86F) NDC: 83254-075 Labels for all sizes CALAMINE nanz relieve calamine lotion lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:83254-076 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - 7.6 g FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 7.6 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZI اقرأ الوثيقة كاملة