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NDC 55526-0016-01 Dr.s Clean Advanced Hand 42 mL/60mL Details

Dr.s Clean Advanced Hand 42 mL/60mL

Dr.s Clean Advanced Hand is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by EQMAXON Corp. The primary component is ALCOHOL.

Product Information

NDC	55526-0016
Product ID	55526-0016_15606713-7cec-4b6c-8676-a23fbca0f597
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	Dr.s Clean Advanced Hand
Proprietary Name Suffix	n/a
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	42
Active Ingredient Units	mL/60mL
Substance Name	ALCOHOL
Labeler Name	EQMAXON Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 55526-0016-01 (55526001601)

Pricing Information	N/A
NDC Package Code	55526-0016-1
Billing NDC	55526001601
Package	60 mL in 1 BOTTLE (55526-0016-1)
Marketing Start Date	2020-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d23af803-95c8-47f3-a0ee-ecbf6c328eae Details

ACTIVE INGREDIENT

Ethyl Alcohol 70.0%

INACTIVE INGREDIENTS

Purified Water, Aloe Extract, Glycerin, Sodium Hyaluronate, Carbomer, Butylene Glycol, Triethanolamine, Flavoring

PURPOSE

ANTISEPTIC

WARNINGS

Flammable. Keep away from fire and flames. For external use only.

When using this product • Do not get into eyes. • If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.

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

KEEP OUT OF REACH OF CHILDREN

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

Uses

for hand-washing to decrease bacteria on the skin, only when water is not available

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision.

Questions

Questions?

+82-31-429-8582 or visit http://www.eqmaxon.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.S CLEAN ADVANCED HAND

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55526-0016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	42 mL in 60 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
Glycerin (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Butylene Glycol (UNII: 3XUS85K0RA)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55526-0016-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/01/2020

Labeler - EQMAXON Corp (557821534)

Registrant - EQMAXON Corp (557821534)

Name	Address	ID/FEI	Business Operations
Establishment
EQMAXON Corp		557821534	manufacture(55526-0016)

Revised: 7/2020

Document Id: 15606713-7cec-4b6c-8676-a23fbca0f597

Set id: d23af803-95c8-47f3-a0ee-ecbf6c328eae

Version: 1

Effective Time: 20200727