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 ADVANCED 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% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only. 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

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

Other information

• do not store above 104 F
• may discolor some fabrics, wood finishes and plastics

Inactive ingredients

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

Puri-Clean Advanced Hand Sanitizer

PURI-CLEAN  ADVANCED HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0358
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0358-3	118 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(58443-0358) , analysis(58443-0358) , label(58443-0358) , pack(58443-0358)

Revised: 4/2022

Document Id: dbe9caca-702b-4bc3-e053-2a95a90a0338

34390-5

Set id: ae551e4e-2fd9-c51a-e053-2a95a90adf41

Version: 2

Effective Time: 20220405