FDA Label for Antibacterial Antiseptic Wet Wipes
View Indications, Usage & Precautions
Antibacterial Antiseptic Wet Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Fresh Co Cosmetics Sh.p.k.. 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.
Active Ingredient(S)
Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Antibacterial Wet Wipes
Use
Decrease bacteria on skin. 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 do not get into eyes, ears, and mouth. If contact occurs,rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash develops and continues for morethan 72 hours. 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 at 1-800-222-1222.
Otc - Stop Use
Stop use and ask a doctor if irritation ordevelops and continues for morethan 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 at 1800-222-1222.
Directions
adults and children 2 years and over
- apply to hands
- wet hands thoroughly with product and allow it to dry
- ask a doctor before use
- to dispense peel back front label slowly remove wipes.
- to reseal pouch firmly run thumb over the label.
- donot flush
children under 2 years
Directions for use
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat
Inactive Ingredients
deionised water, ceteary isononanoate,cetearyl alcohol, glyceryl stearate, glycerin, ceteareth-12, cetyl palmitate, phenoxyethanol, sodium benzoate, fragrance, citric acid, disodium EDTA
Package Label - Principal Display Panel
48 wet wipes NDC: 80638-150-48
102 wet wipes NDC: 80638-150-12
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