Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77482-001-10 - Packager: Shenzhen Youmikai Technology Co., Ltd.
- 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 May 18, 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:77482-001 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 TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.5 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77482-001-10 100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/18/2020 Labeler - Shenzhen Youmikai Technology Co., Ltd. (403062710) Establishment Name Address ID/FEI Business Operations UNIK Technology Shenzhen Co ltd 403062710 manufacture(77482-001)