Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Grupo Algoar de Mexico, S.A. de C.V.
TOPICAL
OTC DRUG
Antiseptic For hand sanitizing
OTC monograph not final
ALGOAR HAND SANITIZER- ALCOHOL GEL GRUPO ALGOAR DE MEXICO, 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._ ---------- ACTIVE INGREDIENT Ethyl Alcohol 70% v/v. PURPOS E Antiseptic US ES For hand sanitizing WARNINGS For external use only. FLAMMABLE. Keep away from heat or flame. WHEN USING THIS PRODUCT keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Do not inhale or ingest. STOP USE AND ASK A DOCTOR IF irritation develop. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or call a Poison Control Center. DIRECTIONS Wet hands thoroughly with product and allow to dry without wiping. For children under 6 use only under adult supervision. OTHER INFORMATION Do not store above 40C (104F). Store in a dry place. INACTIVE INGREDIENTS Water, Glycerin, Carbomer, Aloe vera, Triethanolamine, sucrose octaacetate PRODUCT LABEL ALGOAR HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:78 8 8 4-0 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 70 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC) GLYCERIN (UNII: PDC6 A3C0 OX) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) TRO LAMINE (UNII: 9 O3K9 3S3TK) SUCRO SE O CTAACETATE (UNII: 0 7V59 10 57T) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:78 8 8 4-0 0 1- 0 1 120 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duc t 0 6 /0 1/20 20 2 NDC:78 8 8 4-0 0 1- 0 2 50 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duc t 0 6 /0 1/20 20 3 NDC:78 8 8 4-0 0 1- 10 0 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbina Read the complete document