Label: PYURX- ethanol alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80527-251-50 - Packager: Novara 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 September 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
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:
- Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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.
See ingreditents list for accurate list.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- 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
PYURX
ethanol alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80527-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) 0.1 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 4 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 4 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 3 mL in 100 mL WATER (UNII: 059QF0KO0R) 13.8 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80527-251-50 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/07/2020 Labeler - Novara LLC (117659846) Establishment Name Address ID/FEI Business Operations Novara LLC 117659846 relabel(80527-251) Establishment Name Address ID/FEI Business Operations Huizhou Duomei Daily Necessites Co., LTD. 554530153 manufacture(80527-251)
