País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Calamine 8% and Zinc Oxide 8%
Pierson Laboratories
TOPICAL
OTC DRUG
Skin protectant dries the oozing and weeping o poison ivy, poison oak, and poison sumac.
OTC monograph final
CALAMINE- CALAMINE 8% AND ZINC OXIDE 8% LOTION PIERSON LABORATORIES _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._ ---------- CALAMINE LOTION Drug Facts ACTIVE INGREDIENTS Calamine 8% and Zinc Oxide 8% PURPOS E Skin protectant US ES dries the oozing and weeping o 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 chilren 6 months of age. WHEN USING THIS PRODUCT Discontinue use if condition worsens or does not improve within 7 days and consult a doctor. 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. OTHER INFORMATION Store at room temperature 13-30C (50-86F) INACTIVE INGREDIENTS Bentonite magma, calcium hydroxide, glycerin, purified water. LABEL CALAMINE calamine 8% and zinc oxide 8% lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:4559 1-0 41 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 16 0 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH BENTO NITE (UNII: A3N5ZCN45C) CARRAGEENAN (UNII: 5C6 9 YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) Pierson Laboratories CALCIUM HYDRO XIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETIN Leia o documento completo