Active Ingredients
Benzalkonium Chloride 0.13%
Kids Antiseptic Wipes
FDA Label NDC 76523-098
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valley Of The Sun Cosmetics Llc for the product Kids Antiseptic Wipes (NDC 76523-098). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of babies, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
Antiseptic Wipes are used to help reduce bacteria that potentiallyy 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 years of age, do not use as baby wipe.
- on open skin wounds.
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 Babies
If swallowed, get medical help or contact a poison Control Center right away
Directions
- To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep lid closed to prevent moisture loss.
- Open and unfold wipe
- Thoroughly wipe hands, fingers, and wrists. Be sure to use the entire wipe. Allow to dry.
- For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with the second wipe.
- Discard after single use
- Supervise children under 2 years of age when using this product to avoid swallowing
Other Information
- Store between 15-30°C (59-86°F)
- Avoid freezing and excessive heat above 40°C(104°F)
Inactive Ingredients
Water, glycerin, aloe barbadensis (aloe vera) leaf extract, hydrogen peroxide, tocopheryl acetate (Vitamin E), propylene glycol, peg-60 hydrogenated castor oil, phenoxyethanol
Package Label
Kids Antiseptic 80 wipes, 454g, NDC: 76523-098-090
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