CUIR HAND SANITIZER- alcohol gel 
Comercial Riley S.A. de C.V.

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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CUIR Hand Sanitizer

DRUG FACTS

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Uses

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

Warnings

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

Do not use

  • In chilren less than 2 months of age
  • On open skin wounds

When using this producto

keep out of eyes, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask to a doctor

if irritation or rash occurs. These may be signs of 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

glycerine, hydregen peroxide, purifed water UPS.

Package Labeling:(78514-000-33)

Bottle

Package Labeling:(78514-000-16)

Bottle2

CUIR HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78514-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78514-000-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
2NDC:78514-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/02/2020
Labeler - Comercial Riley S.A. de C.V. (951578468)
Establishment
NameAddressID/FEIBusiness Operations
Comercial Riley S.A. de C.V.951578468manufacture(78514-000)

Revised: 2/2022
Document Id: d8d929f4-27db-2b41-e053-2a95a90abdf3
Set id: 97c234ec-ba60-48e2-8b6b-25b52ab18764
Version: 2
Effective Time: 20220225
 
Comercial Riley S.A. de C.V.