Active Ingredient
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Alcohol Hand Wipes
FDA Label NDC 90083-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Olce Group Kozmetik Kimya Gida Medikal Ve Saglik Urunleri Sanayi Ve Ticaret Ltd Sti for the product Alcohol Hand Wipes (NDC 90083-211). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, otc - when using, stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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.
Otc - 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
lemon oil-distilled, peg-7 glyceryl cocoate, edetic acid, anhydrous citric acid, water, polysorbate 20, cocamidopropyl betaine, dexpanthenol, glycerin
Recent Major Changes
Changed the pre-filled out section for "Use"
Changed the pre-filled out section for "Directions"
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
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