Puri-Clean Advanced Hand Sanitizer

Puri-Clean by

Drug Labeling and Warnings

Puri-Clean by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURI-CLEAN HAND SANITIZER- ethyl alcohol gel 
Prime Enterprises

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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Puri-Clean Advanced Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable

Flammable: Do not use near heat, flame or while smoking.

When using this product

• keep out of eyes. If product gets into eyes, rinse with water to remove. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Directions

• Wet hands thoroughly with product and allow to dry without wiping.
• For children under 6, use only under adult supervision.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

Other information

• Do not store above 104ºF.
• May discolor some fabrics, wood finishes and plastics.

Questions and comments info@makrobeauty.com

Puri-Clean Antibacterial Hand Sanitizer

PURI-CLEAN  HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0480
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	607.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0480-5	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020	04/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/13/2020	04/30/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0480) , analysis(58443-0480) , label(58443-0480) , pack(58443-0480)

Revised: 4/2022

Document Id: dbe9c605-c601-2dee-e053-2995a90a6d42

34390-5

Set id: d2a727eb-f802-4efc-e053-2995a90a6ec7

Version: 2

Effective Time: 20220405