Label: HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81309-004-01, 81309-004-02, 81309-004-03, 81309-004-04, view more81309-004-05, 81309-004-06, 81309-004-07, 81309-004-08, 81309-004-09 - Packager: LYW BIOTECH CO LIMITED GUANGZHOU
- 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 February 20, 2021
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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:81309-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL in 100 mL WATER (UNII: 059QF0KO0R) 36 mL in 100 mL PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) 0.2 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81309-004-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 2 NDC:81309-004-02 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 3 NDC:81309-004-03 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 4 NDC:81309-004-04 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 5 NDC:81309-004-05 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 6 NDC:81309-004-06 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 7 NDC:81309-004-07 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 8 NDC:81309-004-08 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 9 NDC:81309-004-09 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/01/2021 Labeler - LYW BIOTECH CO LIMITED GUANGZHOU (554530905) Establishment Name Address ID/FEI Business Operations LYW BIOTECH CO LIMITED GUANGZHOU 554530905 manufacture(81309-004)