ALCOHOL HAND WIPES- ethyl alcohol cloth 
OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI

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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Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Wipes used on hands and skin to reduce bacteria

Warnings

For external use only, do not ingest. Flammable. Keep away from heat, flame, or direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop Use

Stop use and ask a doctor if irritation or rash occurs and persists for longer than 72 hours. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Supervise use by children under the age of 6.

Directions

Storage

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Inactive Ingredients

lemon oil-distilled, peg-7 glyceryl cocoate, edetic acid, anhydrous citric acid, water, polysorbate 20, cocamidopropyl betaine, dexpanthenol, glycerin

Package Label - Principal Display Panel

120 Count Canister NDC: 90083-211-12

200 Count Canister NDC: 90083-211-20

500 Count Canister NDC: 90083-211-50

Principal Display Panel

ALCOHOL HAND WIPES 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90083-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.059 mL  in 4.37 mL
Inactive Ingredients
Ingredient NameStrength
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
EDETIC ACID (UNII: 9G34HU7RV0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90083-211-502185 mL in 1 CANISTER; Type 0: Not a Combination Product09/07/2020
2NDC:90083-211-20874 mL in 1 CANISTER; Type 0: Not a Combination Product09/07/2020
3NDC:90083-211-12524.4 mL in 1 CANISTER; Type 0: Not a Combination Product09/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/07/2020
Labeler - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355)
Registrant - Huzeyfe Islamoglu (595865355)
Establishment
NameAddressID/FEIBusiness Operations
OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI595865355manufacture(90083-211)

Revised: 9/2020
Document Id: aeafa80e-7011-225c-e053-2995a90a1821
Set id: aeafa80e-701f-225c-e053-2995a90a1821
Version: 1
Effective Time: 20200906
 
OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI