Active Ingredient
Active Ingredients: Benzalkonium Chloride 0.1%
Celavi Hand Sanitizing Wet Wipes
FDA Label NDC 75770-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blanc Mer for the product Celavi Hand Sanitizing Wet Wipes (NDC 75770-010). 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, inactive ingredient, purpose, keep out of reach of children, uses, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid
Purpose
Purpose: antiseptic
Keep Out Of Reach Of Children
Keep out of reach of children:
■ If swallowed, get medical help or contact a Posion Control Center right away
Uses
Uses:
■instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease
■instant hand antiseptic to decrease bacteria on the skin
Warnings
Warnings
For external use only
When using this product
■ if following abnormal symptoms persist, discontinue use
Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes
■ Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
■ When used repeatedly in the same area, skin irritation may occur.
■Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.
It is not recommended to use this one areas that have been medically treated with a cast or bandage.
■Do not use in combination with soap or antibacterial cleansing agents.
Directions
Directions:
■ Scrub and wipe off the hand and skin, which are used individually or if necessary.
Other Information
Other information:
■ Read the directions and warnings before use ■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)
* Please review the disclaimer below.
