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NDC 55526-0010-01 Dr.s Clean Hand 70 g/100mL Details

Dr.s Clean Hand 70 g/100mL

Dr.s Clean 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	55526-0010
Product ID	55526-0010_5ececc12-b893-4c23-ae05-9aeac28286ca
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 Hand
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	g/100mL
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 55526-0010-01 (55526001001)

Pricing Information	N/A
NDC Package Code	55526-0010-1
Billing NDC	55526001001
Package	60 mL in 1 BOTTLE (55526-0010-1)
Marketing Start Date	2020-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fad65262-320f-4348-8932-677c58853991 Details

ACTIVE INGREDIENT

Active ingredients: Ethyl Alcohol 70.0%

INACTIVE INGREDIENT

Inactive ingredients:

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

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

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

Uses:

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

Directions

Directions:

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision.

PACKAGE LABEL - Dr.'s Clean Hand Gel 60mL

PACKAGE LABEL - Dr.'s Clean Hand Gel 500mL

INGREDIENTS AND APPEARANCE

DR.S CLEAN HAND

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55526-0010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g in 100 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
Packaging
1	NDC:55526-0010-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020
2	NDC:55526-0010-2	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2020

Labeler - EQMAXON Corp (557821534)

Registrant - EQMAXON Corp (557821534)

Name	Address	ID/FEI	Business Operations
Establishment
EQMAXON Corp		557821534	manufacture(55526-0010)

Revised: 4/2020

Document Id: 5ececc12-b893-4c23-ae05-9aeac28286ca

Set id: fad65262-320f-4348-8932-677c58853991

Version: 1

Effective Time: 20200407