HAND SANITIZER- ethyl alcohol gel 
Solevy Co.

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.

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Rena Hand Sanitizer 1.5 oz.

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:

  1. Ethyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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 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.

Directions

Other information

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Extract, Glycerin, Carbomer, Aminomethyl Propanol, Tocopherol (Vitamin E), Hydrogen Peroxide, Propylene Glycol, Fragrance.

Package Label - Principal Display Panel

RENA Hand Sanitizer 3 oz.

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75042-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8) 0.001 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.14 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 19.6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75042-001-0145 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2021
2NDC:75042-001-0290 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2020
3NDC:75042-001-03240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2020
4NDC:75042-001-04475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2020
5NDC:75042-001-05950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2020
Labeler - Solevy Co. (056875098)
Registrant - Solevy Co. (056875098)
Establishment
NameAddressID/FEIBusiness Operations
Solevy Co.056875098manufacture(75042-001)

Revised: 1/2023
Document Id: f3991ccd-2451-e192-e053-2a95a90a80f4
Set id: a2e69091-d4b4-aff4-e053-2a95a90a13eb
Version: 4
Effective Time: 20230131
 
Solevy Co.