Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78426-001-01, 78426-001-02, 78426-001-03, 78426-001-04, view more78426-001-05, 78426-001-06 - Packager: BioBarrier360 LLC
- 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 June 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only.
Flammable. Keep away from heat or flame.
When using this product
- Keep out of eyes, ears and mouth. In case of contact with eyes rinse thoroughly with water.
- Directions
- Other information
- Inactive ingredients
- Questions?
- Company Information
- Product Packaging - 500 ml
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78426-001 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 GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78426-001-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 2 NDC:78426-001-02 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 3 NDC:78426-001-03 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 4 NDC:78426-001-04 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 5 NDC:78426-001-05 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 6 NDC:78426-001-06 3785 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 - BioBarrier360 LLC (117535912)