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NDC 55526-0011-01 Dr.s Clean Hand 70 mL/100mL Details

Dr.s Clean Hand 70 mL/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	55526-0011
Product ID	55526-0011_e6b71cc7-4d30-406a-b176-0eed0afb55b5
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	mL/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 55526-0011-01 (55526001101)

Pricing Information	N/A
NDC Package Code	55526-0011-1
Billing NDC	55526001101
Package	500 mL in 1 BOTTLE, PUMP (55526-0011-1)
Marketing Start Date	2020-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5272a305-b1c8-49ae-bf24-116c547dc309 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.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.S CLEAN HAND

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55526-0011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL 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	Marketing End Date
Packaging
1	NDC:55526-0011-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2020

Labeler - EQMAXON Corp (557821534)

Registrant - EQMAXON Corp (557821534)

Name	Address	ID/FEI	Business Operations
Establishment
EQMAXON Corp		557821534	manufacture(55526-0011)

Revised: 4/2020

Document Id: e6b71cc7-4d30-406a-b176-0eed0afb55b5

Set id: 5272a305-b1c8-49ae-bf24-116c547dc309

Version: 1

Effective Time: 20200418