Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75470-410-01, 75470-410-02, 75470-410-03, 75470-410-04 - Packager: Tecnoglobal Ph7, S.a. De C.v.
- Category: HUMAN OTC DRUG LABEL
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 August 25, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75470-410 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 GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) EDETATE SODIUM (UNII: MP1J8420LU) CARBOMER 940 (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75470-410-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:75470-410-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:75470-410-03 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:75470-410-04 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Tecnoglobal Ph7, S.a. De C.v. (813006665) Establishment Name Address ID/FEI Business Operations Tecnoglobal Ph7, S.a. De C.v. 813006665 manufacture(75470-410)