Country: United States
Language: English
Source: NLM (National Library of Medicine)
benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Meizhou Jubona Technology Co., Ltd.
TOPICAL
OTC DRUG
Antiseptic Cleans and refreshes hands and face without soap and water.
OTC monograph not final
HAND WIPES- BENZALKONIUM CHLORIDE SWAB MEIZHOU JUBONA TECHNOLOGY CO., LTD. _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 Benzalkonium Chloride .......... 0.13 % PURPOSE Antiseptic USES: Cleans and refreshes hands and face without soap and water. WARNINGS For external use on hands only. Stop use and ask a doctor if irritation develops. Store and handling Store in a cool place. KEEP OUT OF REACH OF CHILDREN. if swallowed get medical help or contact a Poison Control Center right away. DIRECTIONS Self-dries in seconds. Leave skin soft and smooth. INACTIVE INGREDIENTS: Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2- propandiol, Antibacterial synerists, Stabilizer, Water HAND WIPES benzalkonium chloride swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:82447-101 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) benzalkonium chloride 0.13 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) CHLORPHENESIN CARBAMATE (UNII: 57U5YI11WP) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:82447-101- 01 1.7 g in 1 PACKAGE; Type 0: Not a Combination Product 12/13/2021 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph not final part333A 12/13/2021 Meizhou Jubona Technology Co., Ltd. LABELER - Meizhou Jubona Technology Co., Ltd. (712379455) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Meizhou Jubona Technology Co., Ltd. 712379455 MANUFACTURE(82447-101) Revised: 12/2021 Read the complete document