Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
SC Health SPV, LLC
TOPICAL
OTC DRUG
For hand sanitizing to decrease bacterial on the skin.
OTC monograph not final
SC HEALTH HAND SANITIZER GEL SINGLE USE PACKETS- 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 HAND SANITIZER GEL SINGLE USE PACKETS, 250 PACKETS _DRUG FACTS_ ACTIVE INGREDIENT Ethyl alcohol 75% PURPOSE Antiseptic USES For hand sanitizing to decrease bacterial on the skin. WARNINGS FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME FOR EXTERNAL USE ONLY. DO NOT USE on damaged, inflamated, 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 and rendess develops and lasts 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 throughly with product, allow to dry without wiping. INACTIVE INGREDIENTS acrylates/C 10-30 alkyl acrylate crosspolymer, aloe vera (aloe barbadenis) leaf extract, glycerin, triethanolamine, water. _QUESTIONS?_ www.schealth.com PACKAGE LABELING: SC HEALTH HAND SANITIZER GEL SINGLE USE PACKETS alcohol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:78633-002 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:78633-002- 01 250 in 1 BOX 09/05/2020 12/31/2022 1 1.5 mL in 1 PACKET; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITA read_full_document