Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75470-400-01, 75470-400-02 - Packager: Tecnoglobal Ph7, S.a. De C.v.
- 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 August 25, 2020
If you are a consumer or patient please visit this version.
- 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:75470-400 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 EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) PHENOXYETHANOL (UNII: HIE492ZZ3T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE SODIUM (UNII: MP1J8420LU) CARBOMER 940 (UNII: 4Q93RCW27E) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75470-400-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 03/30/2020 2 NDC:75470-400-02 60 mL in 1 TUBE; 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(75470-400)