Otc - Active Ingredient
Drug Facts
Active Ingredients.........................purpose
Alcohol 62%.....................................antiseptic
Coconut Lime Antibacterial Sanitizer
FDA Label NDC 51201-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Goldessence, Limited for the product Coconut Lime Antibacterial Sanitizer (NDC 51201-200). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, otc - purpose, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Warning. For external use only-hands
Flammable keep away from heat and flame
Otc - When Using
When using this product. keep out of eyes. In case of contact with eyes, flush thoroughly with water,
do not inhale or ingest. avoid contact with broken skin.
Otc - Stop Use
Stop use and ask a doctor if skin irritation develops.
Otc - Keep Out Of Reach Of Children
keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
Dosage & Administration
Directions
Wet hands thoroughly with product and allow to dry with out wiping
For children under 6, use only under adult supervision
not recommended for infants.
Otc - Purpose
Uses:
To decrease germs on the skin
recommended for repeated use.
Information For Patients
Other Information
Do not store above 105oC
May discolor some fabrics
Harmful to wood finishes and plastics
Inactive Ingredient
Inactive Ingredients
Water (aqua), Alcohol, Peg-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Fragrance (parfum) Denatonium Benzoate. May contain FD and C Red No4 (CI14700), FD and C yellow No 5 (CI 19140), FD and C blue no1(CI42090), Dand C Red No 33 (CI17200)
Other
16fl oz/473 ml
Package Label.Principal Display Panel
goldessence bath and body collection
coconut lime
Antibacterial Sanitizer 16floz / 473ml
Coconutlimelabelpdp (Coconutlime Pdp)
Coconutlimepanel (Coconutlime Panel)
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