CLEANSIFIED- alcohol gel 
Cleansified

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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Cleansified Hand Sanitizer

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Consumer 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

on 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

Water, Acrylates Copolymer, Fragrance, Aminomethyl Propanol

Package Label - Principal Display Panel

75673-180-01

75673-180-02

75673-180-08

75673-180-16

75673-180-32

CLEANSIFIED 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75637-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.14 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75637-180-013786 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
2NDC:75637-180-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
3NDC:75637-180-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
4NDC:75637-180-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
5NDC:75637-180-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - Cleansified (117476725)
Registrant - Cleansified (117476725)
Establishment
NameAddressID/FEIBusiness Operations
Cleansified117476725manufacture(75637-180)

Revised: 7/2020
Document Id: a9d9a759-2afd-01ba-e053-2995a90ad976
Set id: a9d9a8be-6de0-8d86-e053-2a95a90a872c
Version: 1
Effective Time: 20200707
 
Cleansified