39.5% Sea Water by OLAOLAB Inc. / Greencos Co., Ltd.

39.5% Sea Water by

Drug Labeling and Warnings

39.5% Sea Water by is a Animal medication manufactured, distributed, or labeled by OLAOLAB Inc., Greencos Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

39.5% SEA WATER- paw in clean for ear from jeju solution/ drops 
OLAOLAB Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredients 

Sea Water 39.5 %

Principal display panel and representative container

PAW in Clean for Ear from Jeju 

Ear cleanser for pets

Ear cleanser for pets to clean even the invisible ear area 

Active ingredients:

Sea Water 39.5%

Inactive ingredients: 

WATER, GLYCERIN, 1,2-HEXANEDIOL, D-PANTHENOL, GLUCONO-δ-LACTONE, 2-AMINO-2-HYDROXYMETHYL-1,3-PROPANEDIOL, DISODIUM EDTA, CITRIC ACID, HOUTTUYNIA EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, DIPROPYLENE GLYCOL, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, SACCHAROMYCES/CARAGANA SINICA ROOT FERMENT EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, OCIMUM BASILICUM (BASIL) LEAF EXTRACT, MONARDA DIDYMA LEAF EXTRACT, MENTHA VIRIDIS (SPEARMINT) EXTRACT, MELISSA OFFICINALIS EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, PULSATILLA KOREANA EXTRACT, BUTYLENE GLYCOL

39.5% SEA WATER 
paw in clean for ear from jeju solution/ drops

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86180-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	39.5 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86180-201-02	1 in 1 PACKAGE
1		100 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/04/2023	06/21/2023

Labeler - OLAOLAB Inc. (695371978)

Registrant - OLAOLAB Inc. (695371978)

Establishment
Name	Address	ID/FEI	Business Operations
Greencos Co., Ltd.		694777325	manufacture, api manufacture

Revised: 6/2023

Document Id: 37658c30-7785-4d43-bbd4-104457e5516d

50577-6

Set id: c44e4e7a-957a-4fbd-9f35-cacd1f934a59

Version: 4

Effective Time: 20230601

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