País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
CJ Global Inc
TOPICAL
OTC DRUG
purpose:Antimicrobial Hand Sanitizer to help reduce bacteria on the skin that may cause disease. Stop use and ask a doctor if imiation or redness develops.
OTC monograph not final
70% ALCOHOL HAND SANITIZER GEL- HAND SANITIZER GEL CJ GLOBAL INC _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._ ---------- NDC REGISTRATION ACTIVE INGREDIENT(S) Ethyl Alcohol 70%±5 v/v. Purpose: Antimicrobial PURPOS E purpose:Antimicrobial US E Hand Sanitizer to help reduce bacteria on the skin that may cause disease. WARNINGS For external use only. Flammable. Keep away from heat or flame When using this product avoid contact with face, eyes, and broken skin . In case of eye contact , flush with plenty of water and seek medical advice. Stop use and ask a doctor if imiation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS wet hands thoroughly with product and rub into skin until dry. children under 6years of age should be supervised by an adult when using. OTHER INFORMATION Store at room temperature,may discolor certain fabrics INACTIVE INGREDIENTS PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 60ml NDC:77372-001-01 70% ALCOHOL HAND SANITIZER GEL hand sanitizer gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:77372-0 0 1 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 8 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) 1 mL in 10 0 mL WATER (UNII: 0 59 QF0 KO0 R) CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E) 0 .4 mL in 10 0 mL TRO LAMINE (UNII: 9 O3K9 3S3TK) 0 .4 mL in 10 0 mL CJ Global Inc PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:77372-0 0 1-0 1 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 5/0 6 /20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE Llegiu el document complet