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NDC 71734-0329-01 Purenique Hygiene Solutions Hand Sanitizer 62 mL/100mL Details

Purenique Hygiene Solutions Hand Sanitizer 62 mL/100mL

Purenique Hygiene Solutions Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.. The primary component is ALCOHOL.

Product Information

NDC	71734-0329
Product ID	71734-329_46223c18-270a-4e42-948f-0ece4009cebc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Purenique Hygiene Solutions Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71734-0329-01 (71734032901)

Pricing Information	N/A
NDC Package Code	71734-329-01
Billing NDC	71734032901
Package	5 mL in 1 DOSE PACK (71734-329-01)
Marketing Start Date	2020-09-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4f4ab6a2-e3f3-4be4-b91d-18b81f7fc624 Details

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Hand sanitizer to helo decrease virus on the skin when water,soap and towel are not available.
recommended for repeared use.

Warnings

For external use only. Avoid contact with the wound. Do not allow this product to come into contact with eyes or nearby.

If you accidently touch a wound or eye, rinse immediately with water.

If skin irritation or sensitivity occurs ,discontinue use and consult your doctor immediately.

Not recommended for infants.

Other information:

Store at 20℃（68 to 77 ℉）in a cool place . May discolor fabrics.

Keep out of reach of children.

Do not allow children under 6 years of age to handle or apply this product，If swallowed ,contact your doctor immediately.

Directions

No water needed . Apply a small amount of product to dry skin.

Inactive Ingredients

Pure Water, Glycerine, Carbomer, Triethanolamine, Disodium EDTA

Product Labeling

INGREDIENTS AND APPEARANCE

PURENIQUE HYGIENE SOLUTIONS HAND SANITIZER

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71734-329
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71734-329-01	5 mL in 1 DOSE PACK; Type 0: Not a Combination Product	09/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/25/2020

Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)

Name	Address	ID/FEI	Business Operations
Establishment
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	manufacture(71734-329)

Revised: 9/2020

Document Id: 46223c18-270a-4e42-948f-0ece4009cebc

Set id: 4f4ab6a2-e3f3-4be4-b91d-18b81f7fc624

Version: 1

Effective Time: 20200925