Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ORCHID & ME ORGANICS & PRODUCTS COMPANY LIMITED
TOPICAL
OTC DRUG
Antiseptic 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 and on open skin wounds
OTC monograph not final
ORCHID AND ME MOISTURIZING HAND SANITIZER- ALCOHOL GEL ORCHID & ME ORGANICS & PRODUCTS COMPANY LIMITED _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._ ---------- ACTIVE INGREDIENT Alcohol 77% v/v. PURPOS E Antiseptic 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 and 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 at 1-800222-1222. DIRECTIONS 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. OTHER INFORMATION Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) QUES TIONS ? 1-800-571-8254 Mon-Fri 9:00 AM- 5:00 PM (EST) INACTIVE INGREDIENTS Aqua, Avena sativa Kernel Oil, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Galactoarabinan, Glycerin, Honey, Sodium Hyaluronate, Triethanolamine PACKAGE LABEL - PRINCIPAL DISPLAY PANEL ORCHID AND ME MOISTURIZING HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:9 0 0 18 -0 0 2 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 77 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) HO NEY Read the complete document