Country: United States
Language: English
Source: NLM (National Library of Medicine)
Ethyl Alcohol 70%, Antiseptic
Grupo Asavalle, S.A. de C.V.
TOPICAL
OTC DRUG
To decrease bacteria on hands.
OTC monograph not final
VEGOL HAND SANI- ALCOHOL GEL GRUPO ASAVALLE, 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._ ---------- VEGOL HAND SANI _DRUG FACTS_ ACTIVE INGREDIENTS Ethyl Alcohol 70% PURPOS E Antiseptic US ES To decrease bacteria on hands. WARNINGS : FLAMMABLE: KEEP AWAY FROM FLAME OR HIGH HEAT. FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT keep out of eyes, STOP USE, AND ASK A DOCTOR if irritation 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 allow to dry without wiping. OTHER INFORMATION: Do not store above 105ºF. May discolor some fabrics. Harmful to wood finishes and plastics. INACTIVE INGREDIENTS: Water, Glycerin, Carbomer, Triethanolamine, polysorbate, Fragrance (Parfume). PACKAGE LABELING: 1L PACKAGE LABELING: 4L VEGOL HAND SANI alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:78 244-0 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 0 .7 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC) TRO LAMINE (UNII: 9 O3K9 3S3TK) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:78 244-0 0 1-0 1 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/0 1/20 20 Grupo Asavalle, S.A. de C.V. 2 NDC:78 244-0 0 1-0 2 40 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 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 rt333E 0 4/0 1/20 20 LABELER - Grupo Read the complete document