Label: HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81309-002-01, 81309-002-02, 81309-002-03, 81309-002-04, view more81309-002-05, 81309-002-06, 81309-002-07, 81309-002-08, 81309-002-09 - Packager: LYW BIOTECH CO LIMITED GUANGZHOU
- 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 13, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- STOP USE
- WHEN USING
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81309-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL in 100 mL TOCOPHERYL NICOTINATE (UNII: WI1J5UCY5C) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 24.17 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81309-002-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 2 NDC:81309-002-02 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 3 NDC:81309-002-03 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 4 NDC:81309-002-04 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 5 NDC:81309-002-05 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 6 NDC:81309-002-06 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 7 NDC:81309-002-07 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 8 NDC:81309-002-08 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 9 NDC:81309-002-09 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2020 Labeler - LYW BIOTECH CO LIMITED GUANGZHOU (554530905) Establishment Name Address ID/FEI Business Operations LYW BIOTECH CO LIMITED GUANGZHOU 554530905 manufacture(81309-002)
