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NDC 71734-0334-01 Dextragel Antiseptic Hand Sanitizer 75 mL/100mL Details

Dextragel Antiseptic Hand Sanitizer 75 mL/100mL

Dextragel Antiseptic 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	71734-0334
Product ID	71734-334_80a651a9-3e85-4b21-b98c-d1ca67ed3dae
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	Dextragel Antiseptic Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	75
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 71734-0334-01 (71734033401)

Pricing Information	N/A
NDC Package Code	71734-334-01
Billing NDC	71734033401
Package	50 PACKAGE in 1 BAG (71734-334-01) / 2 mL in 1 PACKAGE
Marketing Start Date	2020-11-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 95f73d1f-304f-488e-95e6-af7d99ff68ce Details

Active Ingredient

Ethly Alcohol 75%

Purpose

Antiseptic

USES:

hand sanitizer to decrease bacteria on the skin
recommended for repeated use
for use when soap and water are not available

Warnings

For external use only.

Flammable. Keep away from fire/flame.

Do not use

in children less than 2 months of age
open skin wounds

When using this product

do not get into eyes. in case of contat, rinse eyes thoroughly with water
In case of contact with eyes,flush eyes thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Other information

Store between 15-30℃ ( 59-68 ℉)
Avoid freezing and excessive heat above 40℃ (104℉）

Keep out of reach of children.

Keep out of reach of children. If swalllowed ,get medical help or contact poison Control right away.

Directions

wet hand thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product to avoid swallowing

Inactive Ingredients

Glycerine, Carbomer, Triethanolamine, Water

Product Labeling

INGREDIENTS AND APPEARANCE

DEXTRAGEL ANTISEPTIC HAND SANITIZER

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71734-334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71734-334-01	50 in 1 BAG	11/24/2020
1		2 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/24/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	manufacture(71734-334)

Revised: 11/2020

Document Id: 80a651a9-3e85-4b21-b98c-d1ca67ed3dae

Set id: 95f73d1f-304f-488e-95e6-af7d99ff68ce

Version: 1

Effective Time: 20201124