Reduvir Hand sanitizer by Culta S.A. de C.V.

Reduvir Hand sanitizer by

Drug Labeling and Warnings

Reduvir Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Culta S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REDUVIR HAND SANITIZER- ethyl alcohol solution 
Culta 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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Active Ingredient(s)

Ethyl Alcohol 70% v/v

Purpose

Purpose: Antiseptic

Use

to decrease bacteria on the skin that could cause disease. Recommend for repeated use. For use when soap and water are not available.

Warnings

For external use only: hands.

Flammable. Keep away from heat and flame

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes flush thoroughly with water.
Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if

• irritations and redness develop
• condition persists for more than 72 hours.

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.
• For children under 6, use only under adult supervision. Not recommended for infants.

Other information

• Do not store above 105F.
• May discolor some fabrics.
• Harmful to wood finishes and plastics.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel

500 mL NDC: 80358-001-05

1000 mL NDC: 80358-001-10

3785 mL NDC: 80358-001-37

REDUVIR HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80358-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72.38 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80358-001-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020
2	NDC: 80358-001-05	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020
3	NDC: 80358-001-37	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/26/2020	09/03/2020

Labeler - Culta S.A. de C.V. (951578576)

Establishment
Name	Address	ID/FEI	Business Operations
Culta S.A. de C.V.		951578576	manufacture(80358-001)

Revised: 9/2020

Document Id: ae6e5767-5636-9c52-e053-2995a90a29dc

34390-5

Set id: a8fef253-f2f8-0d91-e053-2a95a90ac5ca

Version: 2

Effective Time: 20200903