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NDC 55526-0014-01 ESTHETE HAND SANITIZER 350 mL/500mL Details

ESTHETE HAND SANITIZER 350 mL/500mL

ESTHETE HAND SANITIZER 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	55526-0014
Product ID	55526-0014_90b0b110-cb40-41d8-bb9b-cf6f9273dc98
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	ESTHETE HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	350
Active Ingredient Units	mL/500mL
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 55526-0014-01 (55526001401)

Pricing Information	N/A
NDC Package Code	55526-0014-1
Billing NDC	55526001401
Package	500 mL in 1 BOTTLE, PUMP (55526-0014-1)
Marketing Start Date	2020-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52ae9023-e397-4954-9b53-c69936c9b216 Details

ACTIVE INGREDIENT

Ethyl Alcohol 70.0%

INACTIVE INGREDIENTS

PURIFIED WATER, ALOE EXTRACT, GLYCERIN, SODIUM HYALURONATE, CARBOMER, BUTYLENE GLYCOL, AMINOMETHYL PROPANOL, FRAGRANCE

PURPOSE

ANTISEPTIC

WARNINGS

▪ FOR EXTERNAL USE ONLY ▪ FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME

When using this product

▪Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ▪ Avoid contact with broken skin ▪ Do not inhale or ingest.

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

Uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Directions

▪ DISPENSE ONE TO TWO PUMPS OF SANITIZER ONTO HANDS AND RUB THOROUGHLY UNTIL DRY.

▪ USE AS NEEDED ▪ FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION

▪ NOT RECOMMENDED FOR INFANTS

Other Information

▪ Store below 110 °F(43°C)

▪ May discolor some fabrics

▪ Harmful to wood finishes and plastics

Questions or Comments?

Email : [email protected]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESTHETE HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55526-0014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL in 500 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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55526-0014-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/01/2020

Labeler - EQMAXON Corp (557821534)

Registrant - EQMAXON Corp (557821534)

Name	Address	ID/FEI	Business Operations
Establishment
EQMAXON Corp		557821534	manufacture(55526-0014)

Revised: 5/2020

Document Id: 90b0b110-cb40-41d8-bb9b-cf6f9273dc98

Set id: 52ae9023-e397-4954-9b53-c69936c9b216

Version: 1

Effective Time: 20200530