País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Charlotte Products Ltd.
TOPICAL
OTC DRUG
Antiseptic, Hand Sanitizer Personal hand sanitizing wipe to help reduce bacteria that potentially can cause disease. - 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
ENVIROSOLUTIONS SANITIZING WIPES- ISOPROPYL ALCOHOL CLOTH CHARLOTTE PRODUCTS LTD. _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._ ---------- ENVIROSOLUTIONS ES40 SANITIZING WIPES 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 World Health Organization (WHO) recommendations: a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol (1.45% v/v). c. Hydrogen peroxide (0.125% v/v). d. Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product. ACTIVE INGREDIENT(S) Isopropyl Alcohol 70% v/v. Purpose: Antiseptic PURPOS E Antiseptic, Hand Sanitizer US E Personal hand sanitizing wipe to help reduce bacteria that potentially can cause disease. 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. DIRECTIONS • Open the plastic tab at the front of the bottle. Pull up wipe and replace plastic cap. Always snap lid securely shut between uses to prevent moisture loss. Leia o documento completo