Label: MDR SAFE-IN-SECONDS HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 64483-010-01, 64483-010-02 - Packager: Clientele, 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 October 28, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Company Information
- Product Packaging - 236 mL
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INGREDIENTS AND APPEARANCE
MDR SAFE-IN-SECONDS HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64483-010 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) CHINESE CINNAMON (UNII: WS4CQ062KM) SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y) ROSEMARY (UNII: IJ67X351P9) THYME OIL (UNII: 2UK410MY6B) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) EDETOL (UNII: Q4R969U9FR) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64483-010-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/28/2020 2 NDC:64483-010-02 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/28/2020 Labeler - Clientele, Inc. (085021806)