HAND SANITIZER- alcohol gel
Hand Sanitizer by
Drug Labeling and Warnings
Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Magaña Muela, Jesús, Mario Hidalgo. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active Ingredient(s)
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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.
- Use
- Warnings
- Do not use
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WHEN USING
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. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
- Package Label - Principal Display Panel
- Package Label - Principal Display Panel
- Package Label - Principal Display Panel
- Package Label - Principal Display Panel
- Pachage Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 77934-123 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 CARBOMER 940 (UNII: 4Q93RCW27E) 0.6 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.8 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 5 mL in 100 mL WATER (UNII: 059QF0KO0R) 18 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 77934-123-07 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/16/2020 2 NDC: 77934-123-08 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/16/2020 3 NDC: 77934-123-09 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/16/2020 4 NDC: 77934-123-10 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/16/2020 5 NDC: 77934-123-11 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/16/2020 6 NDC: 77934-123-13 20000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 05/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/16/2020 Labeler - Magaña Muela, Jesús (951577940) Registrant - Mario Hidalgo (080666336) Establishment Name Address ID/FEI Business Operations Magaña Muela, Jesús 951577940 manufacture(77934-123)
3785 mL NDC: 
125 mL NDC: 
250 mL NDC: 
946 mL NDC: 
1893 mL NDC: 
20000 mL NDC: Trademark Results [Hand Sanitizer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAND SANITIZER 88958909 not registered Live/Pending |
MAISON BLANCHE, LLC 2020-06-10 |
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