The following Structured Product Label (SPL) was submitted to the FDA by Artesanales P.r. Llc for the product Isopropyl Rubbing Alcohol 70% (NDC 78824-625). 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 other, otc - active ingredient, otc - purpose, indications & usage, otc - do not use, warnings, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
The hand sanitizer is manufactured using grade ingredients:
Isopropyl Alcohol (USP or Food Chemical Codex) (99% (v/v) in an aqueous solution
water
the firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Isopropyl Alcohol 99% v/v. Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Hand Sanitizer to help reduce bacteria that can potentially cause a disease. For use when soap and water are not available
in children less than 2 onths of age
on open skin wounds
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 irrittion 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.
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.
store between 15-30C (59-86F)
avoid freezing and excessive heat above 40C (104F)
water
Isopropyl Label (Isopropyl)
* Please review the disclaimer below.
