59401-029_Innovative Displays Antibacterial Hand Cloths

Innovative Displays Antibacterial Hand Cloths by

Drug Labeling and Warnings

Innovative Displays Antibacterial Hand Cloths by is a Otc medication manufactured, distributed, or labeled by IMINE CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INNOVATIVE DISPLAYS ANTIBACTERIAL HAND CLOTHS- alcohol cloth 
IMINE CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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59401-029_Innovative Displays Antibacterial Hand Cloths

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Use

• Antiseptic (skin) cleanser
• Medicated (skin) cleanser
• Antibacterial (skin) cleanser
• Effective in destroying (harmful) bacteria to provide antiseptic cleansing
• For personal hand hygiene to help prevent the spread of bacteria

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

• Tear Open individual sachet.
• Place enough product on hands to cover all surfaces.
• Allow to dry
• Supervise children under 6 years of age when using this product.

Other information

• Store between 15°-30°C (59°-86°F) out of direct sunlight.
• Avoid freezing and excessive heat above 40°C (104°F)
• Do not use individual product inside if sachet is opened prior to use.

Inactive ingredients

aqua, butylene glycol, camellia sinensis leaf extract, citral, fragrance, geraniol, glycerin, hexyl cinnamal, limonene, linalool

INNOVATIVE DISPLAYS ANTIBACTERIAL HAND CLOTHS 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59401-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59401-029-02	50 in 1 CARTON	07/15/2020	12/10/2021
1	NDC: 59401-029-01	4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/15/2020	12/10/2021

Labeler - IMINE CO., LTD. (557816813)

Registrant - IMINE CO., LTD. (557816813)

Establishment
Name	Address	ID/FEI	Business Operations
IMINE CO., LTD.		557816813	manufacture(59401-029)

Revised: 12/2021

Document Id: d2d5aba2-a6f9-a7b9-e053-2a95a90af92d

34390-5

Set id: dba1b17c-4d4f-4e7d-9a69-d2f086befeae

Version: 2

Effective Time: 20211210