国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Royal Beauty Group, Llc
TOPICAL
OTC DRUG
Antiseptic Alcohol antiseptic wipe helps reduce harmful bacteria and germs that potentially can cause disease. - in children less than 2 months of age - on open skin wounds
OTC monograph not final
ROYALCARE SANITIZING WIPES- ISOPROPYL ALCOHOL CLOTH ROYAL BEAUTY GROUP, LLC _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 75% v/v. PURPOS E Antiseptic US E Alcohol antiseptic wipe helps reduce harmful bacteria and germs that potentially can cause disease. WARNINGS Flammable, keep away from heat and flame. For external use only. DO NOT USE in children less than 2 months of age on open skin wounds WHEN USING THIS PRODUCT keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF irritation or rash occurs. These may be signs of a serious condition. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS To dispense, lift cover, open the bag, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep cap closed to prevent moisture loss. Use entire wipe to thoroughly wipe hands, surfaces. To sanitize, use multiple wipes. Discard after single use. OTHER INFORMATION Store at room temperature15° C~30° C (59° F~86°) Avoid freezing and excessive heat above 40° C (104° F) INACTIVE INGREDIENTS glycerin, hydrogen peroxide, purified water USP NET CONTENTS 800 wipes; dimension: 14cm X 20cm (5.5” X 8”) spunlace nonwoven fabric; net weight 4.2kg (9.2lbs) PACKAGE LABEL - PRINCIPAL DISPLAY PANEL ROYALCARE SANITIZING WIPES isopropyl alcohol cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 0 759 -8 0 1 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 75 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) HYDRO GEN PERO XIDE (UNII: BBX0 阅读完整的文件