Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
SC Health SPV, LLC
TOPICAL
OTC DRUG
for hand sanitizing to decrease bacteria on the skin.
OTC monograph not final
SC HEALTH INSTANT HAND SANITIZER- ALCOHOL GEL SC HEALTH SPV, 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._ ---------- SC HEALTH INSTANT HAND SANITIZER DRUG FACTS _ACTIVE INGREDIENT_ Ethyl alcohol 75% _PURPOSE_ Antiseptic _USE_ for hand sanitizing to decrease bacteria on the skin. _WARNINGS_ FLAMMABLE,KEEP AWAY FROM FIRE OR FLAME FOR EXTERNAL USE ONLY DO NOT USE on damaged,inflamed,or broken skin. WHEN USING THIS PRODUCT avoid contact with eyes. in case of contact with eyes,rinse thoroughly with water. STOP USE AND ASK A DOCTOR IF irritation or redness develops and lasts for more than 72 hours. KEEP OUT OF REACH OF CHILLDREN. If swallowed,get medical help or contact a Poison Control Center right away. _DIRECTIONS_ wet hands thoroughly with product. allow to dry without wiping. _INACTIVE INGREDIENTS_ acrylates/C 10-30 alkyl acrylate crosspolymer,aloe vera(aloe barbadensis)leaf extract,glycerin,triethanolamine,water. _QUESTIONS?_ www.schealthspv.com PACKAGE LABELING: 20ML PACKAGE LABELING: 50ML PACKAGE LABELING: 100ML PACKAGE LABELING: 200ML PACKAGE LABELING: 500ML SC HEALTH INSTANT HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:78633-000 ROUTE OF ADMINISTRATION TOPICAL SC Health SPV, LLC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.75 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:78633-000- 01 20 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2020 12/31/2022 2 NDC:78633-000- 02 50 mL in 1 BOTTLE; Type 0: Not a Co Citiți documentul complet