ALCOHOL HAND WIPES- ethyl alcohol cloth

Alcohol Hand Wipes by

Drug Labeling and Warnings

Alcohol Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Fuson LLC, OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

ALCOHOL HAND WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78141-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3.059 mL  in 4.37 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78141-211-50	2185 mL in 1 CANISTER; Type 0: Not a Combination Product	09/16/2020
2	NDC: 78141-211-20	874 mL in 1 CANISTER; Type 0: Not a Combination Product	09/16/2020
3	NDC: 78141-211-12	524.4 mL in 1 CANISTER; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/16/2020

Labeler - Fuson LLC (113376279)

Registrant - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355)