Otc - Active Ingredient
Ethyl alcohol 69% v/v
Paume Moisturizing Antibacterial Hand Gel
FDA Label NDC 80328-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Paume Inc for the product Paume Moisturizing Antibacterial Hand Gel (NDC 80328-123). 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 - keep out of reach of children, dosage & administration, warnings, inactive ingredient, indications & usage, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Put enough product in your palm to cover hands and rub together thoroughly until dry. Children under the age of 5 should be supervised by an adult when using this product.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use -in children less than 2 years of age -on open skin wounds.
When using this product - keep out of eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if -irritation and redness develop.
Inactive Ingredient
Purified water, Witch Hazel Extract, Safflower oleosomes in glycerin and aqua, Hydroxypropyl Methylcellulose, Cedarwood Essential Oil, Lavender Essential Oil, Rosemary Essential Oil, Lemon Essential Oil, Orange Essential Oil, Aloe Vera Powder 200X (certified organic).
Indications & Usage
To help reduce bacteria on the skin.
Otc - Purpose
Antimicrobial
Package Label.Principal Display Panel
Principal Display Panel (Capture.jpg)
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