Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Henan Lingrui Biopharmaceutical Co., Ltd
TOPICAL
OTC DRUG
For hygienic hand antisepsis. Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - on children less than 2 months of age - on open skin wounds - in the eyes. in case of contact, rinse eyes thoroughly with water Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
OTC monograph not final
LINGRUI HAND ANTISEPTIC RINSE FREE- HAND SANITIZER GEL HENAN LINGRUI BIOPHARMACEUTICAL CO., 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._ ---------- LINGRUI, SANITIZER, ETHANOL 68%, GEL ACTIVE INGREDIENT(S) Ethanol 68% v/v. Purpose: Antiseptic PURPOS E For hygienic hand antisepsis. US E Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. WARNINGS Flammable. For external use only. Keep away from heat or flame. 1. Only external use, oral administration is prohibited. 2. Keep out of reach of children. 3. Those who are allergic to this product (alcohol, ethanol) are contraindicated. DO NOT USE on children less than 2 months of age on open skin wounds in the eyes. in case of contact, rinse eyes thoroughly with water 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 and redness develop and persist for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Apply appropriate amount of this product to wash both hands and scrub for 1-3mins. OTHER INFORMATION Store in sealed, cool and dark condition. INACTIVE INGREDIENTS Purified Water, Glycerol, Carbomer, Trolamine, Triclosan. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL LINGRUI HAND ANTISEPTIC RINSE FREE hand sanitizer gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:42217-0 110 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 40 .6 mL in 6 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) TRICLO SAN (UNII: 4NM50 39 Y5X) TRO LAMINE (UNII: 9 O3K9 3S3TK) WATER Read the complete document