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NDC 54748-0201-07 EO HAND SANITIZER 62 mL/100mL Details

EO HAND SANITIZER 62 mL/100mL

EO HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by EO Products, LLC. The primary component is ALCOHOL.

Product Information

NDC	54748-0201
Product ID	54748-201_a597e3af-cb5f-45d8-a63a-76f24f651240
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	EO HAND SANITIZER
Proprietary Name Suffix	Lavender
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	EO Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54748-0201-07 (54748020107)

Pricing Information	N/A
NDC Package Code	54748-201-07
Billing NDC	54748020107
Package	946 mL in 1 BOTTLE (54748-201-07)
Marketing Start Date	2017-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 36b26803-ed48-498f-bc0e-15473495a35a Details

Active Ingredients:

Ethanol 62%

Purpose:

Antiseptic

Uses:

• For hand washing to decrease bacteria on skin.

• Recommended for repeated use.

Warnings:

• Flammable, keep away from fire or flame.

• For external use only.

• Do not use in eyes. If contact occurs, flush thoroughly with water.

• Stop use and ask doctor if redness and irritation develops and persists for more than 72 hours.

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

Directions:

• Wet hands thoroughly with product and allow to dry without wiping.

• Do not use other than directed.

Other Information:

Store below 104°F (40°C)
May discolor certain fabrics.

Inactive Ingredients:

Purified Water, Vegetable Glycerin, EO® Essential Oil Blend [Organic Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil], Organic Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Dimethicone, Aminomethyl Propanol

SPL UNCLASSIFIED SECTION

ESSENTIAL OILS

HAND sanitizer GEL

french lavender

99.9% EFFECTIVE AGAINST MOST COMMON GERMS

made with moisturizing ingredients

SYNTHETIC FRAGRANCE FREE

TRICLOSAN FREE • BENZALKONIUM CHLORIDE FREE

MADE WITH ORGANIC INGREDIENTS • PHTHALATE FREE

EO® PRODUCTS

SMALL WORLD TRADING CO.

SAN RAFAEL, CA 94901

MADE IN THE USA FROM DOMESTIC AND GLOBALLY SOURCED INGREDIENTS

800-570-3775 eoproducts.com

Packaging

INGREDIENTS AND APPEARANCE

EO HAND SANITIZER LAVENDER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54748-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDIN OIL (UNII: 9RES347CKG)
JOJOBA OIL (UNII: 724GKU717M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54748-201-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2013	10/31/2016
2	NDC:54748-201-03	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2013	10/31/2016
3	NDC:54748-201-04	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2013	10/31/2016
4	NDC:54748-201-05	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2017
5	NDC:54748-201-09	6 in 1 BOX	08/13/2018
5	NDC:54748-201-05	59 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:54748-201-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2017
7	NDC:54748-201-07	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2017
8	NDC:54748-201-17	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/15/2013

Labeler - EO Products, LLC (786611210)

Name	Address	ID/FEI	Business Operations
Establishment
EO Products, LLC		786611210	manufacture(54748-201)

Revised: 6/2022

Document Id: a597e3af-cb5f-45d8-a63a-76f24f651240

Set id: 36b26803-ed48-498f-bc0e-15473495a35a

Version: 9

Effective Time: 20220608