Active Ingredient(S)
Alcohol 10% w/w
Benzalkonium Chlorid 0. 1%w/w
Poly( hexamethylenebiguanide )hydro-chloride 0.05%w/w
Didecyl Dimethylammonium Chloride 0.3%w/w
Cleansing Disinfection Wipes
FDA Label NDC 78293-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Bolicen Bio-technology Co., Ltd. for the product Cleansing Disinfection Wipes (NDC 78293-008). 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(s), purpose, use, warnings, do not use, otc - when using, otc - 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
Use
USE FOR HAND AND SKIN SURFACE DISINFECTING AND CLEANSING
Warnings
For extemal use only. Keep away from sunlight, store in a cool, dry place
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 and sore or broken skin, If contact with eyes occurs, rinse thoroughly with water.top use and ask a doctor if irritation or rash occurs, These may be signs of a serious condition Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed
Otc - Stop Use
Stop use and ask a doctor if imitation or rash occurs, These may be signs of a serious condition
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed
Directions
Open lid, For first time user, remove tamper evident seal, Pullout wipes as needed. Close the lid after use each time top revent moisture loss
Other Information
Do not store above 40 °C. May discolor some fabrics and surfaces
Store between15-30°C
Inactive Ingredients
Water
Package Label - Principal Display Panel
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