ALCOHOL HAND WIPES- ethyl alcohol cloth 
Fuson LLC

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 (Ethanol) 70%

Inactive Ingredients

Aqua, glycerin, peg-7 glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, dexpanthenol, citrus limon peel, citric acid, EDTA

Purpose

Antiseptic- Antibacterial hand towelettes

Use

Wipes used on hands and skin to reduce bacteria

Warnings

For external use only, do not ingest. Do not use near eyes. Keep away from flame and 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

Do not use near eyes. Do not ingest. Do not eat, smoke, or drink during use. Do not use on or in open skin wounds. Do not use on children under 2 months of age.

When Using

If ingested, contact a poison control center immediately. If eye contact occurs, flush eyes with water repeatidly.

Stop Use

Stop use if redness, irritation, or rash occurs.

Store in places out of reach of children. Supervise use by children under the age of 6.

Dierctions

Peel back open label slowly. Pull out one wipe at a time and re-seal the packaging tightly. Wet hands thoroughly with product and allow to dry without wiping.

Storage

Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.

Package Label

120 Count Canister: 78141-211-12

200 Count Canister: 78141-211-20

500 Count Canister: 78141-211-50

78141-211-20

ALCOHOL HAND WIPES 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78141-211
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
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
EDETIC ACID (UNII: 9G34HU7RV0)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78141-211-502185 mL in 1 CANISTER; Type 0: Not a Combination Product09/16/2020
2NDC:78141-211-20874 mL in 1 CANISTER; Type 0: Not a Combination Product09/16/2020
3NDC:78141-211-12524.4 mL in 1 CANISTER; Type 0: Not a Combination Product09/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/16/2020
Labeler - Fuson LLC (113376279)
Registrant - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355)

Revised: 8/2020
Document Id: ad654143-1c45-51c1-e053-2a95a90a1b7b
Set id: ad654143-1c44-51c1-e053-2a95a90a1b7b
Version: 1
Effective Time: 20200821
 
Fuson LLC