Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78349-0002-2, 78349-0002-3, 78349-0002-4, 78349-0002-5 - Packager: Biozone Chemical, S. de R.L. de C.V.
- 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 24, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE AND ADMINISTRATION
- INACTIVE INGREDIENTS
- INDICATIONS AND USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- WARNINGS
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WARNINGS AND PRECAUTIONS
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 eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- ASK DOCTOR
- PACKAGING LABELS
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78349-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL in 1 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.2585 mL in 1 mL TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78349-0002-2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2020 2 NDC:78349-0002-3 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2020 3 NDC:78349-0002-4 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2020 4 NDC:78349-0002-5 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/22/2020 Labeler - Biozone Chemical, S. de R.L. de C.V. (812910867) Registrant - Biozone Chemical, S. de R.L. de C.V. (812910867) Establishment Name Address ID/FEI Business Operations Biozone Chemical, S. de R.L. de C.V. 812910867 manufacture(78349-0002)
