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NDC 81158-0010-01 ALL A ECO CLEANER 750 mL/1000mL Details

ALL A ECO CLEANER 750 mL/1000mL

ALL A ECO CLEANER is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by All Human M Korea. The primary component is ALCOHOL.

Product Information

NDC	81158-0010
Product ID	81158-010_4b24995f-3ccd-495e-8294-2ac38813068a
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	ALL A ECO CLEANER
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethanol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	750
Active Ingredient Units	mL/1000mL
Substance Name	ALCOHOL
Labeler Name	All Human M Korea
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 81158-0010-01 (81158001001)

Pricing Information	N/A
NDC Package Code	81158-010-01
Billing NDC	81158001001
Package	1000 mL in 1 CONTAINER (81158-010-01)
Marketing Start Date	2020-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8f55af83-3266-4817-baa4-79d033498e19 Details

ACTIVE INGREDIENT

Ethanol 75 % v/v

INACTIVE INGREDIENT

Water

PURPOSE

Antimicrobial

WARNINGS

For external use only

Flammable. Keep away from heat 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 skin irritation or rash 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

■ Disinfectant to help reduce bacteria on the skin and surfaces

■ Recommended for repeated use

Directions

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

■ Store between 15-30℃(59-86℉)

■ Avoid freezing and excessive heat above 40℃(104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL A ECO CLEANER

ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81158-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	750 mL in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81158-010-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	11/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/01/2020

Labeler - All Human M Korea (695504144)

Registrant - All Human M Korea (695504144)

Name	Address	ID/FEI	Business Operations
Establishment
Seoul Food Research & Development Co., Ltd.		688787758	manufacture(81158-010)

Revised: 11/2020

Document Id: 4b24995f-3ccd-495e-8294-2ac38813068a

Set id: 8f55af83-3266-4817-baa4-79d033498e19

Version: 1

Effective Time: 20201123