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 OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI, Huzeyfe Islamoglu. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age
• on open skin wounds
• near eyes

WHEN USING

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

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

• Peel back open label slowly
• Pull out one wipe at a time
• Reseal packaging tightly
• Wet hands thoroughly with product and allow to dry
• Supervise children under 6 years of age when using this product to avoid ingestion

Storage

• Avoid freezing and excessive heat above 40C (104F)
• Store away from direct sunlight
• Store tightly closed in its original packaging
• Keep away from food, drinks, and animal feed
• Store in places unaccessible to children

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

INGREDIENTS AND APPEARANCE

ALCOHOL HAND WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90083-211
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90083-211-50	2185 mL in 1 CANISTER; Type 0: Not a Combination Product	09/07/2020
2	NDC: 90083-211-20	874 mL in 1 CANISTER; Type 0: Not a Combination Product	09/07/2020
3	NDC: 90083-211-12	524.4 mL in 1 CANISTER; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

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

Registrant - Huzeyfe Islamoglu (595865355)

Establishment
Name	Address	ID/FEI	Business Operations
OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI		595865355	manufacture(90083-211)