Label: NURINSE- hand sanitizer hocl aloe and vitamin e gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77368-388-05, 77368-388-08, 77368-388-12, 77368-388-16, view more77368-388-55, 77368-388-75 - Packager: NuGenTec
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- HOCL 385ppm
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
HOCl solutions are already included in the WHO list of coronavirus-effective biocides, and in the US EPA ‘N’ list of disinfecting agents able to control emerging pathogens like SARS-CoV-2. 37,126 More than ten branded aqueous HOCl formulations have been cleared by the US FDA for topical use in wound management over the last decade. A Class III medical product approval for HOCl has been granted in the EU, and the Japanese Ministry of Health has approved use of HOCl for topical medical applications. The US FDA has approved HOCl for high level disinfection and sterilization of medical instruments, including those for use at critical (i.e., sterile) sites
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
NURINSE
hand sanitizer hocl aloe and vitamin e gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77368-388 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID 0.000385 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) 7 g in 100 mL WATER (UNII: 059QF0KO0R) ALOE (UNII: V5VD430YW9) 0.0005 g in 100 mL VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2) 0.0005 g in 100 mL Product Characteristics Color white (Clear Color) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77368-388-05 18927 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 2 NDC:77368-388-55 208198 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 3 NDC:77368-388-75 10409875 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 4 NDC:77368-388-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 5 NDC:77368-388-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 6 NDC:77368-388-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/05/2020 Labeler - NuGenTec (090331927) Registrant - NuGenTec (090331927) Establishment Name Address ID/FEI Business Operations NuGenTec 090331927 manufacture(77368-388)
3785 mL NDC: 77368-388-01
