Label: SAN-EZ HAND SANITIZER- ethyl alcohol 70% gel
- NDC Code(s): 55346-3302-1
- Packager: Dental Technologies, Inc.
- 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.
Drug Label Information
Updated April 8, 2020
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- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
SAN-EZ HAND SANITIZER
ethyl alcohol 70% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-3302 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 .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) DIMETHYL BENZYL CARBINOL (UNII: N95NCI59MI) TRICYCLODECENYL PROPIONATE (UNII: 7MGZ636C87) 4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC) BENZYL BENZOATE (UNII: N863NB338G) CARBOMER 980 (UNII: 4Q93RCW27E) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) LINALOOL, (+/-)- (UNII: D81QY6I88E) ACETYL CEDRENE (UNII: X6I62755AK) ACETYL HEXAMETHYL TETRALIN (UNII: 360Q8Z01IP) CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) CITRAL (UNII: T7EU0O9VPP) 2-METHYL-4-PHENYL-2-BUTANOL (UNII: 9Y5UX90TZ4) BENZYL ACETATE (UNII: 0ECG3V79ZJ) LINALYL ACETATE (UNII: 5K47SSQ51G) BENZYL SALICYLATE (UNII: WAO5MNK9TU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-3302-1 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/08/2020 Labeler - Dental Technologies, Inc. (148312838) Registrant - Dental Technologies, Inc. (148312838) Establishment Name Address ID/FEI Business Operations Dental Technologies, Inc. 148312838 manufacture(55346-3302) , pack(55346-3302) , label(55346-3302)