Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78294-002-01, 78294-002-02, 78294-002-03, 78294-002-04, view more78294-002-05, 78294-002-06, 78294-002-07 - Packager: LOTUS ARTS CRAFTS LIMITED
- 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 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WARNINGS
- PURPOSE
- INDICATIONS & USAGE
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78294-002 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 WATER (UNII: 059QF0KO0R) 36.6 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78294-002-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 2 NDC:78294-002-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 3 NDC:78294-002-03 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 4 NDC:78294-002-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 5 NDC:78294-002-05 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 6 NDC:78294-002-06 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 7 NDC:78294-002-07 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/22/2020 Labeler - LOTUS ARTS CRAFTS LIMITED (551468927) Registrant - LOTUS ARTS CRAFTS LIMITED (551468927) Establishment Name Address ID/FEI Business Operations LOTUS ARTS CRAFTS LIMITED 551468927 manufacture(78294-002)
