Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Paramount Enterprise, LLC
TOPICAL
OTC DRUG
Purpose Antiseptic Uses - for hand sanitizing to decrease bacteria on the skin. - recommended for repeated use.
OTC monograph not final
PARAMOUNT HAND SANITIZER- ALCOHOL LIQUID PARAMOUNT ENTERPRISE, 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._ ---------- PARAMOUNT HAND SANITIZER LIQUID _DRUG FACTS_ _ACTIVE INGREDIENT_ Alcohol 80% _PURPOSE_ Antiseptic _USES_ for hand sanitizing to decrease bacteria on the skin. recommended for repeated use. _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE AND FLAME. WHEN USING THIS PRODUCT keep away from eyes. In case of contact, flush eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF irritation or redness develop or persist for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Wet hands thoroughly with product Rub hands together until dry. Supervise children under 6 years old Not recommended for infants _OTHER INFORMATION_ Store between 15°-30°C (59°-86°F). Avoid freezing and excessive heat above 40ºC (104ºF) _INACTIVE INGREDIENTS_ Glycerin, Vitamin E, Hydrogen peroxide, Purified Water DISTRIBUTED BY PARAMOUNT ENTERPRISES 18566 Office Park Drive, Montgomery Village MD 20886, USA www.paramountenter.com Made in Pakistan Ethanol 80% Paramount HAND SANITIZER Helps prevent bacterial infections ALCOHOL 80% ANTISEPTIC FORMULA LIQUID 236 ML (8 FL OZ) PARAMOUNT HAND SANITIZER alcohol liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:79 78 8 -0 0 1 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 Paramount Enterprise, LLC INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING Read the complete document