Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Sokol and Company
TOPICAL
OTC DRUG
to decrease bacteria on the skin
OTC monograph not final
NEW HORIZON HAND SANITIZER- ALCOHOL GEL SOKOL AND COMPANY _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._ ---------- NEW HORIZON HAND SANITIZER _DRUG FACTS_ _ACTIVE INGREDIENT_ Alcohol 70% v/v _PURPOSE_ Antiseptic _USES_ to decrease bacteria on the skin _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME WHEN USING THIS PRODUCT keep away from eyes. In case of eye contact, rinse eyes with water. STOP USE AND ASK A DOCTOR if irritation or redness develop or last more than 72 hours KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately. _DIRECTIONS_ apply liberally to hands to cover all surfaces rub hands together until dry supervise children under 6 years old not recommended for infants _OTHER INFORMATION_ store between 15-30C (59-86F) avoid freezing and excessive heat above 40 C (104 F) _INACTIVE INGREDIENTS_ glycerin, methylcellulose, purified water PACKAGE LABELING: NEW HORIZON HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 1215-0 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 0 .7 mL in 1 mL Sokol and Company INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) METHYLCELLULO SE, UNSPECIFIED (UNII: Z9 44H5SN0 H) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:8 1215-0 0 0 -0 1 1.7 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 12/0 8 /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 8 /20 20 LABELER - Sokol and Company (005122197) Revised: 12/2020 Olvassa el a teljes dokumentumot