Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
HONGWON COSTECH CO.,LTD.
TOPICAL
OTC DRUG
Antiseptic Store under 30°C (86°F)
OTC monograph not final
CALLICOS HAND GEL SANITIZER- ALCOHOL GEL HONGWON COSTECH 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 Alcohol Water, Carbomer, Triethanolamine, etc. Antiseptic KEEP OUT OF REACH OF THE CHILDREN Store under 30°C (86°F) For external use only. Flammable, keep away from fire or flame. When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. wet hands thoroughly with product briskly rub hands together until dry supervise children under 6 years in the use of this product CALLICOS HAND GEL SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:746 47-0 0 0 2 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 6 2 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) HONGWON COSTECH CO.,LTD. PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:746 47-0 0 0 2- 1 250 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 4/0 1/20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333A 0 4/0 1/20 20 LABELER - HONGWON COST ECH CO.,LT D. (688356002) REGISTRANT - HONGWON COST ECH CO.,LT D. (688356002) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS HONGWON COSTECH CO.,LTD. 6 8 8 356 0 0 2 ma nufa c ture (746 47-0 0 0 2) Revised: 4/2020 Đọc toàn bộ tài liệu