Country: United States
Language: English
Source: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Zhejiang Jiayan Daily Commodity Co., Ltd.
TOPICAL
OTC DRUG
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
ANTIBACTERIAL HAND WIPES- HAND SANITIZER CLOTH ZHEJIANG JIAYAN DAILY COMMODITY 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._ ---------- ACTIVE INGREDIENT(S) Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic PURPOS E Antiseptic, Hand Sanitizer US E Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. WARNINGS For external use only. Flammable. Keep away from heat or flame DO NOT USE in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Apply to hands, allow to dry without wiping. OTHER INFORMATION Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor fabrics INACTIVE INGREDIENTS Disodium EDTA, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 15 Wipes in 1 BAG NDC: 42003-020-01 PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 40 Wipes in 1 BAG NDC: 42003-020-02 ANTIBACTERIAL HAND WIPES hand sanitizer cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:420 0 3-0 20 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6 JUD5X6 Y) BENZALKONIUM CHLORIDE 0 .13 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE Read the complete document