The following Structured Product Label (SPL) was submitted to the FDA by Consolidated Chemicals, Llc for the product Freshands Instant Hand Sanitizer Gel (NDC 75632-230). 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 70% alcohol gel sanitizer, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
This hand sanitizer is an over the counter drug product manufactured with active and inactive ingredients provided below:
Active Ingredient: Ethyl Alcohol 70% v/v
Inactive Ingredients: water, acrylate copolymer, glycerin, hydroxypropyl methylcellulose, aloe barbadensis, tocopheryl acetate, triethanolamine, fragrance
Manufacturing of this hand sanitizer is consistent with 21 CFR Part 310.
Alcohol 70% v/v. Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.
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.
water, acrylate copolymer, glycerin, hydroxypropyl methylcellulose, aloe barbadensis, tocopheryl acetate, triethanolamine, fragrance
3800 mL NDC: 75632-230-40
* Please review the disclaimer below.
