Raloy Pharma Hand Sanitizing Gel - 75% Alcohol

Raloy Pharma Hand Sanitizer Gel by

Drug Labeling and Warnings

Raloy Pharma Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Raloy Lubricantes, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RALOY PHARMA HAND SANITIZER GEL- alcohol gel 
Raloy Lubricantes, S.A. de C.V.

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Raloy Pharma Hand Sanitizing Gel - 75% Alcohol

Ethyl alcohol 75% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease
Recommended for repeated use

For external use only.

Flammable. Keep away from fire or flame.

When using this product keep out of eyes.

In case of contact with eyes, flush thoroughly with water

Avoid contact on broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation or rash occurs.

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

Wet hand thoroughly with product and rub into skin until dry.

Children under 6 years of age should be supervised when using this product.

Store between 15-30ºC (59-89ºF)

Avoid freezing and excessive heating 40ºC (104ºF)

Water, Glycerin, Aminomethylpropanol, Acrylates copolymer.

250 mL NDC: 79587-100-01

350 mL NDC: 79587-100-02

500 mL NDC: 79587-100-03

3785 mL NDC: 79587-100-04

20000 mL NDC: 79587-100-05

RALOY PHARMA HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79587-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79587-100-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
2	NDC: 79587-100-02	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
3	NDC: 79587-100-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
4	NDC: 79587-100-07	20000 mL in 1 CANISTER; Type 0: Not a Combination Product	07/27/2020
5	NDC: 79587-100-06	3785 mL in 1 JUG; Type 0: Not a Combination Product	07/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/27/2020	04/01/2024

Labeler - Raloy Lubricantes, S.A. de C.V. (811259498)

Revised: 11/2023

Document Id: 0a4f2ee3-07f0-0445-e063-6394a90a6499

34390-5

Set id: ab70bb9c-a128-ebb7-e053-2a95a90a4487

Version: 4

Effective Time: 20231116