Otc - Active Ingredient
Active Ingredient Purpose
Alcohol 62% v/v. Antiseptic
Alcohol Antispetic 62% Topical Solution Hand Sanitizer
FDA Label NDC 77041-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wink Naturals, Llc for the product Alcohol Antispetic 62% Topical Solution Hand Sanitizer (NDC 77041-002). 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, purpose, otc - keep out of reach of children, use, warnings, do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
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.
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Water, Fragrance, Carbomer, PEG-40 Hydrogenated Castor Oil, Chlorphenesin, Aminomethyl Propanol
Package Label - Principal Display Panel
Wink Naturals
Alcohol Antiseptic 62% Topical Solution
Hand Sanitizer
Non-sterile
4 FL OZ (118 mL)
* Please review the disclaimer below.
