Label: INSTANT HAND SANITIZER- alcohol gel
- NDC Code(s): 0404-5988-01, 0404-5988-02, 0404-5988-03, 0404-5988-04
- Packager: Henry Schein, 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 January 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL – 800 mL Box Label
- PRINCIPAL DISPLAY PANEL – 1.68 mL Pouch
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INGREDIENTS AND APPEARANCE
INSTANT HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-5988 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 665 mL in 1000 mL Inactive Ingredients Ingredient Name Strength aloe (UNII: V5VD430YW9) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-5988-01 800 mL in 1 BOX; Type 0: Not a Combination Product 02/07/2012 2 NDC:0404-5988-02 1.68 mL in 1 POUCH; Type 0: Not a Combination Product 02/07/2012 3 NDC:0404-5988-03 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/07/2012 4 NDC:0404-5988-04 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/07/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/07/2012 Labeler - Henry Schein, Inc. (012430880) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(0404-5988)