Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Panacea Life Sciences
TOPICAL
OTC DRUG
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
PANAHEALTH INSTANT HAND SANITIZER- HAND SANITIZER GEL PANACEA LIFE SCIENCES _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry. 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 the Center for Disease Control (CDC) recommendations: a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (62%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Sterile distilled water or boiled cold water. The firm adds inactive ingredients that do not effect the activity of the primary ingredient. ACTIVE INGREDIENT(S) Alcohol 62% v/v. Purpose: Antiseptic PURPOS E Antiseptic, Hand Sanitizer US E 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 DO NOT USE in children less than 2 months of age on open skin wounds 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. DIRECTIONS Place enough product on ha Baca dokumen lengkap