Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
KOLORCURE CORPORATION
TOPICAL
OTC DRUG
Antimicrobial in or around the eys.
OTC monograph not final
SANI-KURE EXTRA STRENGTH HAND SANITIZER- ALCOHOL SOLUTION KOLORCURE CORPORATION _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) Alcohol 70% v/v. Purpose: Antimicrobial USE USE: Antimicrobial WARNINGS Flammable. Keep away from heat or flame. Harmful if swallowed. For external use only. DO NOT USE in or around the eys. In case of contact immediately flush eyes with water. If swallowed, contact physician. Keep out of reach of children. DIRECTIONS Place enough product in your palm to cover hands. Rub hands together until dry. Children under 6 years of age should be supervised when using Sani-Kure. OTHER INFORMATION Do not store above 110°F. INACTIVE INGREDIENTS Pure Aloe Vera, vegetable glycerin, isopropyl alcohol, hydrogen peroxide, distilled water. WARNINGS Keep out of reach of children. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 32 FL OZ (946 mL) 128 oz (3800 mL) (1 Gal) SANI-KURE EXTRA STRENGTH HAND SANITIZER alcohol solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:78923-001 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 74 mL in 100 mL KOLORCURE CORPORATION INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 15 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 2.1 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 1.8 mL in 100 mL WATER (UNII: 059QF0KO0R) 7.1 mL in 100 mL PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:78923- 001-38 3800 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2020 2 NDC:78923- 001-32 946 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2020 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE Lire le document complet