The following Structured Product Label (SPL) was submitted to the FDA by Mcclain's Health Llc for the product Mcclains Extra Strength And Moisture Hand Sanitizer Original (NDC 81150-001). 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, 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.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with CDC recommendations:
Formulation:
Formulation (Img 0810 Min)
Isopropyl Alcohol 75% v/v. Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Purpose (Purpose)
Hand Sanitizer to help reduce bacteria on the skin.
Purpose (Purpose)
For external use only. Flammable. Keep away from heat or flame
Formulation (Img 0810 Min)
Formulation (Img 0810 Min)
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.
Formulation (Img 0810 Min)
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Formulation (Img 0810 Min)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Formulation (Img 0810 Min)
Formulation (Img 0810 Min)
Formulation (Img 0810 Min)
USP Purified Water, Organic Aloe Leaf Juice, Phenoxyethanol, Glycerin, Withc Hazel Water, Alcohol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate, Essential Oils.
Formulation (Img 0810 Min)
- Changed usage to reflect exact wording on label.
- Added image of instructions to Dosage form
60 ml NDC: 81150-001-01
* Please review the disclaimer below.
