国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
KEY QUIMICA S.A. DE C.V.
TOPICAL
OTC DRUG
Antiseptic To decrease bacteria on skin that could cause diseases. Recommended for repeated use. this product in or near the eyes. Stop use if irritation or redness develop. if conditions persist for more than 72 hours, consult a doctor.
OTC monograph not final
NOVOSPRAY- ALCOHOL SPRAY KEY QUIMICA S.A. DE C.V. _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._ ---------- 58345-200 ACTIVE INGREDIENT(S) Alcohol 70% v/v. Purpose: Antiseptic PURPOSE Antiseptic USE To decrease bacteria on skin that could cause diseases. Recommended for repeated use. WARNINGS Flammable, keep away from fire or flame. For external use only. DO NOT USE this product in or near the eyes. Stop use if irritation or redness develop. if conditions persist for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, seek immediate medical attention or call a poison control center. DIRECTIONS Wet hands thoroughly with product and allow to dry without wiping. INACTIVE INGREDIENTS Water (aqua), glycerin, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benzoate. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL NOVOSPRAY alcohol spray PRODUCT INFORMATION KEY QUIMICA S.A. DE C.V. PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:58345-200 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:58345- 200-01 12 in 1 BOX 03/30/2020 1 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58345- 200-02 12 in 1 BOX 03/30/2020 2 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58345- 200-03 6 in 1 BOX 03/30/2020 3 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58345- 200-04 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:58345- 阅读完整的文件