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NDC 54699-0001-01 ESTACION HAND SANITIZER ANTIBACTERIAL 75 mL/100mL Details

ESTACION HAND SANITIZER ANTIBACTERIAL 75 mL/100mL

ESTACION HAND SANITIZER ANTIBACTERIAL is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ouya Cosmetics Co., Ltd of Yiwu. The primary component is ALCOHOL.

Product Information

NDC	54699-0001
Product ID	54699-001_a44be22f-a312-9985-e053-2995a90a57df
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	ESTACION HAND SANITIZER ANTIBACTERIAL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Ouya Cosmetics Co., Ltd of Yiwu
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 54699-0001-01 (54699000101)

Pricing Information	N/A
NDC Package Code	54699-001-01
Billing NDC	54699000101
Package	30 mL in 1 BOTTLE (54699-001-01)
Marketing Start Date	2020-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL caee408c-1e2a-4924-b96a-b30a36994350 Details

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antimicrobial

Use

To reduce bacteria on the skin

Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame

For external use only.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or redness occur and persist

SPL UNCLASSIFIED SECTION

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

Directions

Wet hands thoroughly with product and rub until dry
For children under 6, use only under adult supervision

Other information

Do not store above 110F (43C)

May discolor some fabrics or surfaces

Inactive ingredients

Water, propylene glycol, glycerin, carbomer, aloe barbadensis leaf extract, aminomethyl propanediol, tocopheryl acetate

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ESTACION HAND SANITIZER ANTIBACTERIAL

alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54699-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54699-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
2	NDC:54699-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
3	NDC:54699-001-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
4	NDC:54699-001-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
5	NDC:54699-001-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
6	NDC:54699-001-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
7	NDC:54699-001-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2020

Labeler - Ouya Cosmetics Co., Ltd of Yiwu (546464926)

Name	Address	ID/FEI	Business Operations
Establishment
Ouya Cosmetics Co., Ltd of Yiwu		546464926	manufacture(54699-001)

Revised: 4/2020

Document Id: a44be22f-a312-9985-e053-2995a90a57df

Set id: caee408c-1e2a-4924-b96a-b30a36994350

Version: 1

Effective Time: 20200427

Search by Drug Name or NDC

NDC 54699-0001-01 ESTACION HAND SANITIZER ANTIBACTERIAL 75 mL/100mL Details

ESTACION HAND SANITIZER ANTIBACTERIAL 75 mL/100mL

Product Information

Package

Package Images

NDC 54699-0001-01 (54699000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL caee408c-1e2a-4924-b96a-b30a36994350 Details

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Purpose

Use

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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