Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Unishield
TOPICAL
OTC DRUG
First aid antiseptic first aid to help prevent infection in minor cuts, scrapes and burns - near eyes or mucous membranes - on deep or puncture wounds , animal bites, or serious burns - over large areas of the body - more than one week unless directed by a doctor if condition persists or gets worse
OTC monograph not final
FIRST AID ANTISPETIC- BENZALKONIUM CHLORIDE SPRAY UNISHIELD _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._ ---------- UNISHIELD FIRST AID ANTISEPTIC SPRAY _ACTIVE INGREDIENT_ Benzalkonium chloride 0.13% _PURPOSE_ First aid antiseptic _USES_ first aid to help prevent infection in minor cuts, scrapes and burns _WARNINGS_ FOR EXTERNAL USE ONLY FLAMMABLE KEEP AWAY FROM FIRE OR FLAME DO NOT USE near eyes or mucous membranes on deep or puncture wounds , animal bites, or serious burns over large areas of the body more than one week unless directed by a doctor STOP USE AND ASK A DOCTOR if condition persists or gets worse KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ clean affected area & spray 1 to 3 times daily may be covered with a sterile bandage not to be used on children under 12 of years of age _INACTIVE INGREDIENTS_ ethyl alcohol, purified water _QUESTIONS OR COMMENTS_ 1-800-480-5855 PACKAGE LABEL - PRINCIPAL DISPLAY PANEL FIRST AID ANTISPETIC benzalkonium chloride spray PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:49314-0001 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZ ALKONIUM CHLORIDE 0.13 mg in 1 mL Unishield INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:49314- 0001-1 59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/20/2023 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph not final part333A 03/20/2023 LABELER - Unishield (790677053) Revised: 3/2023 Citiți documentul complet