Active Ingredient
Benzalkonium Chloride 0.1%
Claravie Lotion
FDA Label NDC 61554-315
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Claravie (NDC 61554-315). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic / Antibacterial
Uses
- For hand washing to decrease bacteria on skin.
- Recommended for repeated use
- for body wash to help reduce bacteria that can potentially cause disease
Warnings
For external use only
Do Not Use
- on wounds or damaged skin
- on a child under 12 years of age
Ask A Doctor Before Use If You Have
redness over the affected area.
When Using This Product
- use only as directed
- avoid contact with eyes or mucous membranes.
Stop Use And Ask A Doctor If
- condition persists or gets worse.
- Do not use longer than 1 week unless directed by a doctor.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply to hands and wet as needed, vigorously work into a lather and rinse thoroughly.
Other Information
Store at room temperature.
Inactive Ingredients
Water, Sodium Laureth Sulfate, Triethanolamine Lauryl Sulfate, Cocamidopropyl Betaine (CAPB), Cocamide MEA, Polyquaternium 7, Sodium Chloride, Glyceryl Distearate, Sodium Benzoate, PEG-7 Glyceryl Cocoate, Fragrance, Sodium C14-15 Olefin Sulfonate, Methylchloroisothiazolinone and Methylisothiazolinone, Aloe Barbadensis Gel, Butyrospermum Parkii (Shea Butter), Citric Acid, D&C RED # 33, D&C YELLOW # 10
Otc - Questions
1-800-840-9041
- www.gentell.com
Antibacterial Lotion Soap
Antibacterial Lotion Soap Label:
* Please review the disclaimer below.
