Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Kryolan Corporation
TOPICAL
OTC DRUG
Antiseptic Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap or water are not available.
OTC monograph not final
KRYOLAN HAND SANITIZER E- ETHYL ALCOHOL SOLUTION KRYOLAN CORPORATION _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._ ---------- KRYOLAN PROFESSIONAL MAKE-UP HAND SANITIZER E DRUGS FACTS ACTIVE INGREDIENT ETHYL ALCOHOL 80%V/V PURPOS E Antiseptic US ES Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap or water are not available. WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME. DO NOT USE in children less than 2 month of age on open skin wounds WHEN USING THIS PRODUCT keep out of eyes, ears, 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 Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. OTHER INFORMATION Store between 15-30 °C (59-86 °F) Avoid freezing and excessive heat above 40 °C (104 °F) INACTIVE INGREDIENTS glycerin, hydrogen peroxide, purified water USP Topical Solution non-sterile solution KRYOLAN.COM Complies with FDA standards According WHO recommendation KRYOLAN CORPORATION 364 BLODGETT STREET COTATI, CA 94931 USA TEL.: +1 415/863 9684 Made in USA PACKAGING KRYOLAN HAND SANITIZER E ethyl alcohol solution PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:748 74-8 0 0 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 8 0 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) WATER (UNII: 0 Read the complete document