Active Ingredient(S)
Ethyl alcohol 75% v/v. Purpose: Antimicrobial
Antibacterial Hand Sanitizer
FDA Label NDC 76816-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Accompany Usa Inc for the product Antibacterial Hand Sanitizer (NDC 76816-113). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antibacterial
Use
For handwashing to decrease bacteria on the skin.
Warnings
Flammable. Keep away from fire or flame.
Do Not Use
For external use only.
Otc - When Using
When using this product avoid contact with eyes.
If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops and continues for 72 hours.
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.
Directions
- Take a palmful (5grams) of product in one hand.
- Spread on both hands and rub into skin until dry (approximately 1 to 2 minutes).
Other Information
- Do not store above 86℉(30℃)
- May discolor some fabrics
- Harmful to wood finishes and plastics
Inactive Ingredients
Water, Carbomer, Glycerin, 2-Amino-2-methyl-1-propanol, Fragrance.
Package Label - Principal Display Panel
76816-113 (76816 113)
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