CleenScent Hand Sanitizer Gel 330 ml

CleenScent Hand Sanitizer Gel by

Drug Labeling and Warnings

CleenScent Hand Sanitizer Gel 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 GEL- isopropyl alcohol gel 
XMA Servicios de Manufactura S de RL de CV

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CleenScent Hand Sanitizer Gel 330 ml

This is a hand sanitizer manufactured according to the Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020).

The hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product, with percentages iof the active ingredient consistent with the above mentioned final rule, Isopropyl Alcohol (70%, v/v).

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Hand Sanitizer

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

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

-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.

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.

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

glycerin, purified water USP, carbomer, trolamine

330 ml NDC: 78108-1704-4

CLEENSCENT HAND SANITIZER GEL 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78108-1704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78108-1704-4	330 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	08/04/2020	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(78108-1704)

Revised: 12/2024

Document Id: 28f05174-efb7-d739-e063-6294a90a5b13

34390-5

Set id: ac38da41-ff3b-50f0-e053-2a95a90add71

Version: 2

Effective Time: 20241210

 

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