البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
GuStar Co., Ltd.
TOPICAL
OTC DRUG
Antiseptic Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.
OTC monograph not final
GUSTAR CLEAN WET TISSUE- ISOPROPYL ALCOHOL CLOTH GUSTAR CO., LTD. _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._ ---------- ACTIVE INGREDIENT Isopropyl Alcohol 45% INACTIVE INGREDIENT Deionized water PURPOSE Antiseptic WARNINGS ■ For external use only. ■ Flammable. ■ Keep away from heat and Flame. ------------------------------------------------------------------ When using this product ■ Keep out of eyes, ears and mouth. ■ If contact occurs, rinse eyes thoroughly with water. ------------------------------------------------------------------ Stop use and ask a doctor ■ If irritation and rash occurs. KEEP OUT OF REACH OF CHILDREN ■ lf swallowed, get medical help or contact a Poison Control Center right away. US ES Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available. DIRECTIONS ■ Wet hands thoroughly with product and rub hands together until dry. ■ Supervise children under 6 years of age when using. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL GUSTAR CLEAN WET TISSUE isopropyl alcohol cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:738 19 -0 0 0 8 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL - UNII:ND2M416 30 2) ISOPROPYL ALCOHOL 0 .45 INACTIVE INGREDIENTS GuStar Co., Ltd. INGREDIENT NAME STRE NG TH WA TER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:738 19 -0 0 0 8 -1 10 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct 12/0 1/20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333E 12/0 1/20 20 LABELER - GuStar Co., Ltd. (694234583) REGISTRANT - GuStar Co., Ltd. (694234 اقرأ الوثيقة كاملة