Otc - Active Ingredient
Active Ingredient - Triclosan 0.115%
Antibacterial
FDA Label NDC 71020-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sante Manufacturing Inc for the product Antibacterial (NDC 71020-008). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - when using, 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 for handwashing to decrease bacteria on the skin
Warnings
Warning for external use only
Otc - Stop Use
Stop us and ask a doctor if irritation or redness develops
Otc - When Using
When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions
- Wet Hands
- apply palmful to hands
- scrub thoroughly
- rinse
Inactive Ingredient
Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow#5, Red# 33
Package Label.Principal Display Panel
Spa Soap Anitibacterial 1x (Spasoapus Antiback Jan2015 Page 001)
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