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NDC 54748-0103-05 EO HAND SANITIZER 62 mL/100mL Details

EO HAND SANITIZER 62 mL/100mL

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

Product Information

NDC	54748-0103
Product ID	54748-103_83c9cbf8-9b76-4091-894a-eb8337b88fef
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	Sweet Orange
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
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 54748-0103-05 (54748010305)

Pricing Information	N/A
NDC Package Code	54748-103-05
Billing NDC	54748010305
Package	59 mL in 1 BOTTLE, SPRAY (54748-103-05)
Marketing Start Date	2017-05-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7eaf8843-b034-4b11-a962-858941c37444 Details

Active Ingredients:

Organic Ethanol 62%

Purpose:

Antiseptic

Uses:

• For hand washing to decrease bacteria on skin

• Recommended for repeated use

Warnings:

Flammable, keep away from fire/flame
For external use only
Do not use in eyes. If contact occurs, flush thoroughly with water.
Stop use and ask a doctor if redness and irritation develop and persists for more than 72 hours.

SPL UNCLASSIFIED SECTION

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 intended.

Other Information:

• Store below 104°F (40°C).

• May discolor certain fabrics.

Inactive Ingredients:

Purified Water, Organic Lavandula Angustifolia (Lavender) Oil, Organic Citrus Aurantium Dulcis (Orange) Peel Oil, Organic Citrus Medica Limonum (Lemon) Peel Oil, Vegetable Glycerin, Tocopherol

SPL UNCLASSIFIED SECTION

ESSENTIAL OILS

USDA ORGANIC

HAND sanitizer SPRAY

sweet orange

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

CERTIFIED ORGANIC BY CCOF

Packaging

INGREDIENTS AND APPEARANCE

EO HAND SANITIZER SWEET ORANGE

alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54748-103
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)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54748-103-02	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/15/2013	11/30/2016
2	NDC:54748-103-05	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/02/2017
3	NDC:54748-103-09	6 in 1 BOX	08/13/2018
3	NDC:54748-103-05	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

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(54748-103)

Revised: 2/2021

Document Id: 83c9cbf8-9b76-4091-894a-eb8337b88fef

Set id: 7eaf8843-b034-4b11-a962-858941c37444

Version: 6

Effective Time: 20210219

Search by Drug Name or NDC

NDC 54748-0103-05 EO HAND SANITIZER 62 mL/100mL Details

EO HAND SANITIZER 62 mL/100mL

Product Information

Package

Package Images

NDC 54748-0103-05 (54748010305)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7eaf8843-b034-4b11-a962-858941c37444 Details

Active Ingredients:

Purpose:

Uses:

Warnings:

SPL UNCLASSIFIED SECTION

Directions:

Other Information:

Inactive Ingredients:

SPL UNCLASSIFIED SECTION

Packaging

INGREDIENTS AND APPEARANCE

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