Label: 70% ADVANCED ALCOHOL GEL SANITIZER IV- ethyl alcohol gel
- NDC Code(s): 65601-100-03
- Packager: Betco Corporation, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated August 26, 2020
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- Drug Facts
- Active ingredient
For external use only.
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
• Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours,
consult a physician. • KEEP OUT OF REACH OF CHILDREN.
• If swallowed, get medical help or contact a Poison Control Center right away.
- Other information
- Inactive ingredients
INGREDIENTS AND APPEARANCE
70% ADVANCED ALCOHOL GEL SANITIZER IV
ethyl alcohol gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-100 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 WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-100-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/19/2020 Labeler - Betco Corporation, LTD (024492831) Registrant - RealChem Manufacturing Inc (117584702)