Aleva Sani Gel Alcohol Antiseptic 70% Topical Solution

Aleva Sani Gel Alcohol Antiseptic 70 by

Drug Labeling and Warnings

Aleva Sani Gel Alcohol Antiseptic 70 by is a Otc medication manufactured, distributed, or labeled by The River City Soap Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALEVA SANI GEL ALCOHOL ANTISEPTIC 70- alcohol gel 
The River City Soap Company, Inc.

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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Aleva Sani Gel Alcohol Antiseptic 70% Topical Solution

Drug Facts

Active Ingredient

Alcohol 70.0% v/v

Purpose

Antiseptic

Uses

  • 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

  • in children less than 2 months of age
  • on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly 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.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to prevent swallowing.

Other Information

  • Store between 13-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water (aqua), carbomer, hydrogen peroxide, glycerin, fragrance (parfum)

Package Labeling:81054-000-01

Label

Package Labeling:81054-000-02

Label2

Package Labeling:81054-000-03

Label3

ALEVA SANI GEL ALCOHOL ANTISEPTIC 70 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81054-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81054-000-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/202012/28/2022
2NDC: 81054-000-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/202012/28/2022
3NDC: 81054-000-03208198 mL in 1 DRUM; Type 0: Not a Combination Product11/30/202012/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/30/202012/28/2022
Labeler - The River City Soap Company, Inc. (787395974)

Revised: 12/2021
Document Id: d35e7407-2d0b-a4c1-e053-2995a90a9947
Set id: b3ffee19-572a-1847-e053-2995a90a86ac
Version: 2
Effective Time: 20211217