NO CHANGES CERTIFICATION ResQue1st Instant Hand Sanitizer

ResQue1st Hand Sanitizer by

Drug Labeling and Warnings

ResQue1st Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CALIDAD Y SERVICIO VIAN S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RESQUE1ST HAND SANITIZER- alcohol gel 
CALIDAD Y SERVICIO VIAN 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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NO CHANGES CERTIFICATION ResQue1st Instant Hand Sanitizer

ResQue1st Hand Sanitizer Gel

Drug Facts

Active Ingredient(s)

Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from source of heat, fire or flame.

For external use only.

When using this product

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and lasts.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.
• Children under 6 years should be supervised when using this product.

Storage

• Store at a temperature below 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Glycerine, Hydroxyethylcellulose, Purified water USP

Package Label - Principal Display Panel

RESQUE1ST HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79787-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79787-003-01	3790 mL in 1 JUG; Type 0: Not a Combination Product	05/14/2020
2	NDC: 79787-003-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
3	NDC: 79787-003-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
4	NDC: 79787-003-04	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
5	NDC: 79787-003-05	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/14/2020	01/01/2021

Labeler - CALIDAD Y SERVICIO VIAN S.A. DE C.V. (951578030)

Registrant - CALIDAD Y SERVICIO VIAN S.A. DE C.V. (951578030)

Establishment
Name	Address	ID/FEI	Business Operations
CALIDAD Y SERVICIO VIAN S.A. DE C.V.		951578030	manufacture(79787-003)

Revised: 7/2021

Document Id: c7400f2b-bba1-cc17-e053-2995a90ae2d7

34390-5

Set id: ab0ee3c4-9743-10f1-e053-2a95a90a64ca

Version: 15

Effective Time: 20210716