Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Nugale Pharmaceutical Inc
TOPICAL
OTC DRUG
Antiseptic Antiseptic and Hand Sanitizer to help reduce bacteria that may cause disease. For use when soap & water are unavailable.
OTC monograph not final
BENEMAX ADVANCED HAND SANITIZER- ISOPROPYL ALCOHOL LIQUID NUGALE PHARMACEUTICAL INC _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._ ---------- DRUG FACTS ACTIVE INGREDIENT Isopropyl alcohol 70%, USP PURPOSE Antiseptic WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME. DO NOT USE • on children less than 2 months 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. DIRECTIONS • Place enough product on hands or affected area to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing. USES ANTISEPTIC AND HAND SANITIZER to help reduce bacteria that may cause disease. For use when soap & water are unavailable. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away at 1-800- 222-1222. INACTIVE INGREDIENT Water OTHER INFORMATION Store between 15 °C and 30 °C. Avoid freezing and excessive heat above 400 °C (104 °F) PRODUCT LABEL BENEMAX ADVANCED HAND SANITIZER isopropyl alcohol liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:73700-004 ROUTE OF ADMINISTRATION TOPICAL Nugale Pharmaceutical Inc ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:73700- 004-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2021 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR Lesen Sie das vollständige Dokument