CleenScent Hand Sanitizer Non-Sterile Solution by XMA Servicios de Manufactura S de RL de CV

CleenScent Hand Sanitizer Non-Sterile Solution by

Drug Labeling and Warnings

CleenScent Hand Sanitizer Non-Sterile Solution by is a Otc medication manufactured, distributed, or labeled by XMA Servicios de Manufactura S de RL de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEENSCENT HAND SANITIZER NON-STERILE SOLUTION- isopropyl alcohol liquid 
XMA Servicios de Manufactura S de RL de CV

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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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 thoroughly 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.

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 avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

240 ml Spray NDC: 78108-1753-3 240ml Flip Top NDC: 78108-1753-4 355 ml FlipTop NDC: 78108-1753-5 355 ml Spray NDC: 78108-1753-6 2 Liter NDC: 78108-1753-7 1 Gallon NDC: 78108-1753-8

CLEENSCENT HAND SANITIZER NON-STERILE SOLUTION 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78108-1753
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78108-1753-3	240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2020
2	NDC: 78108-1753-4	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020
3	NDC: 78108-1753-5	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020
4	NDC: 78108-1753-6	355 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2020
5	NDC: 78108-1753-7	2000 mL in 1 JUG; Type 0: Not a Combination Product	10/01/2020
6	NDC: 78108-1753-8	3780 mL in 1 JUG; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/01/2020	12/31/2020

Labeler - XMA Servicios de Manufactura S de RL de CV (951577310)

Establishment
Name	Address	ID/FEI	Business Operations
XMA Servicios de Manufactura S de RL de CV		951577310	manufacture(78108-1753)

Revised: 12/2024

Document Id: 28f00836-6d79-bbf7-e063-6394a90aa68d

34390-5

Set id: b2c4f40c-a966-cbc5-e053-2a95a90ae57a

Version: 2

Effective Time: 20241210

 

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