Label: ASSURED HAND SANITIZER WITH VITAMIN E- alcohol liquid
- NDC Code(s): 33992-4947-1, 33992-4947-2, 33992-4947-8
- Packager: Greenbrier International Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 8, 2012
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- ACTIVE INGREDIENT
Ethyl Alcohol 70% v/vClose
- INDICATIONS & USAGE
Uses • hand sanitizer to help reduce bacteria on the skin •recommended for repeated use.Close
Warnings •Flammable. • Keep away from fire and flame. •For external use onlyClose
- WHEN USING
When using this product •avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin.Close
Discontinue use if irritation develops. If condition persists for more than 72 hours, consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. Children should only use this product under adult supervision. Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.Close
- SPL UNCLASSIFIED SECTION
Other information • do not store above 105F. May discolor some fabrics. • Harmful to wood finishes and plasticsClose
- DOSAGE & ADMINISTRATION
Directions • place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. • recommended for repeated useClose
- INACTIVE INGREDIENT
Inactive ingredients carbomer, fragrance, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, tocopheryl acetate, waterClose
- INGREDIENTS AND APPEARANCE
ASSURED HAND SANITIZER WITH VITAMIN E
ethyl alcohol liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-4947 Route of Administration TOPICAL DEA Schedule 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 GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-4947-8 236 mL in 1 BOTTLE, PUMP 2 NDC:33992-4947-1 295 mL in 1 BOTTLE, PUMP 3 NDC:33992-4947-2 355 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2012 Labeler - Greenbrier International Inc. (610322518)