Otc - Active Ingredient
Active ingredient
Benzalkonium chloride 0.13%
Simplify Antibacterial Hand Wipes Cloth
FDA Label NDC 11822-0286
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Simplify Antibacterial Hand Wipes (NDC 11822-0286). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antibacterial
Indications & Usage
Uses · to decrease bacteria on the skin
· recommended for repeated use
Warnings
Warnings
For external use only
Otc - When Using
When using this product keep away from eyes.
In case of eye contact, rinses eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness
develop or last more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical
help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
· rub wipe thoroughly over all surfaces of both hands
· allow to dry without wiping
· supervise children under 6 years old
· not recommended for infants
· dispose of wipe in trash; do not flush
Inactive Ingredient
Inactive ingredients
Water, Alcohol Denat., Phenoxyethanol, PEG-8 Dimethicone, Caprylyl Glycol, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Potassium Sorbate, Disodium EDTA, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice
Package Label.Principal Display Panel
1 Wipe
5.0 IN × 7.8 IN
(12.7 cm × 19.8 cm)
NDC: 11822-0286-1
24 Wipes
Individually Wrapped
5.0 IN × 7.8 IN
(12.7 cm × 19.8 cm)
NDC: 11822-0286-2
40 Wipes
5.7 IN × 7.5 IN
(14.5 cm × 19.05 cm)
NDC: 11822-0286-3
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