Purezza Dakia Wellness Alcohol Antiseptic

Purezza Dakia Wellness Alcohol Antiseptic by

Drug Labeling and Warnings

Purezza Dakia Wellness Alcohol Antiseptic by is a Otc medication manufactured, distributed, or labeled by JAIFAR INTERNATIONAL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PUREZZA DAKIA WELLNESS ALCOHOL ANTISEPTIC- alcohol gel 
JAIFAR INTERNATIONAL 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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Purezza Dakia Wellness Alcohol Antiseptic

Drug Facts

Active Ingredients

Alcohol 70% v/v

Porpose

Antiseptic

Use

as a hand sanitizer gel for cleaning assistance. This Product DOES NOT replace hand washing with soap and water.

Warnings

Flammable, keep away from fire and flames. For external use only.
Read label before use.

When using this product.

In case of contact with eyes, rinse eyes thoroghly with water. 

Stop use and ask a doctor

if skin irritation occurs.

Keep out of reach of children.

Directions.

Place product on hands rub together and let dry.

Other information

*Kills 99.99 % of E.coli, Salmonella spp. and P. aeruginosa.

Inactive Ingredients

Water, carbomer, aminomethyl propanol, glycerin.

Package Labeling:60ml

Package Labeling:250ml

Package Labeling:490ml

Package Labeling:3780ml

PUREZZA DAKIA WELLNESS ALCOHOL ANTISEPTIC 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80824-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80824-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020	11/01/2021
2	NDC: 80824-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020	11/01/2021
3	NDC: 80824-001-03	490 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020	11/01/2021
4	NDC: 80824-001-04	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020	11/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/30/2020	11/01/2021

Labeler - JAIFAR INTERNATIONAL LLC (039647500)

Revised: 11/2021

Document Id: d00d1d06-2660-1702-e053-2a95a90adc5f

34390-5

Set id: b17d1c2d-0d3f-99c0-e053-2a95a90aca31

Version: 2

Effective Time: 20211105