CLEENSCENT HAND SANITIZER GEL- isopropyl alcohol gel 
XMA Servicios de Manufactura S de RL de CV

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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CleenScent Hand Sanitizer Gel

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

Front and back label for CllenScent Hand Sanitizer Gel 60 ml60 ml NDC: 78108-1704-2

CLEENSCENT HAND SANITIZER GEL 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78108-1704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78108-1704-260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/04/2020
Labeler - XMA Servicios de Manufactura S de RL de CV (951577310)
Establishment
NameAddressID/FEIBusiness Operations
XMA Servicios de Manufactura S de RL de CV951577310manufacture(78108-1704)

Revised: 8/2020
Document Id: ac26ca3a-717f-39c4-e053-2a95a90a5e79
Set id: ac26d3b8-4d5b-4ae4-e053-2a95a90a928c
Version: 1
Effective Time: 20200804
 
XMA Servicios de Manufactura S de RL de CV