FDA Label for Whiteday Antibacterial Wet Towels
View Indications, Usage & Precautions
Whiteday Antibacterial Wet Towels Product Label
The following document was submitted to the FDA by the labeler of this product Akgun Cocuk Bezi Ve Kozmetik Urunleri Sanayi Ticaret Limited Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Benzalkonium Chloride (0.45%, volume/volume (w/v)) in an aqueous solution.
- Glycerol (0.8% w/v).
- Phenoxyethanol (0.1% w/v).
- Cocamidopropyl Betaine (0.4% w/v).
- Polysorbate 20 (0.2% w/v).
- Peg-7 Glyceryl Cocoate (0.3% w/v).
- Citric Acid (0.1% w/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Benzalkonium Chloride 0.45% w/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes. 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. 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.
Directions
- Open package, remove one wet wipes to clean your hands and body. Reseal, keep closed to prevent evaporation.
- Allow to dry without wiping. Discard properly after use.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store at room temperature.
- Do not flush down toilet.
Inactive Ingredients
Citric acid, Cocoamidopropyl betaine, glycerin, Phenoxyethanol, Polysorbate 20, Peg-7 glyceryl cocoate, purified water USP
Package Label - Principal Display Panel
72 pcs NDC: 86812-002-01
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