CLEANSE PURE- alcohol solution 
Frozen Wheels, Llc

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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cleansepure

Drug Facts

Active ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use[s]

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

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.

Directions

Other Information

Inactive Ingredients

demineralized water, glycerin, carbomer, aloe vera extract, triethanolamine, disodium EDTA.

NON-STERILE SOLUTION

Made in Mexico.

Imported by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

Distributed by:

Distribu LLC

Packaging

image description

CLEANSE PURE 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77031-505
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77031-505-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
2NDC:77031-505-014000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - Frozen Wheels, Llc (069055731)

Revised: 6/2020
Document Id: e57fe79f-84e2-4d85-85d2-ed695c8e7bc2
Set id: f517bc9d-f35e-4a56-ab36-51554fa26c0c
Version: 2
Effective Time: 20200605
 
Frozen Wheels, Llc