Country: United States
Language: English
Source: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Santa Cruz Biotechnology, Inc.
TOPICAL
OTC DRUG
Antimicrobial Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use.
OTC monograph not final
ULTRACRUZ HAND SANITIZING GEL- ISOPROPYL ALCOHOL GEL SANTA CRUZ BIOTECHNOLOGY, INC. _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._ ---------- ULTRACRUZ HAND SANITIZING GEL This is a hand sanitizer manufactured according to the Tentative Final Monograph for TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE, Title 21, PART 333, CFR Title 21 Volume 5 Chapter I Subchapter D Part 333 Part 333 - Topical Antimicrobial Drug Products For Over-the-counter Human Use PART 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source:52 FR 47322, Dec. 11, 1987, unless otherwise noted. Three sizes. (1) 89 ml NDC: 90032-214-83 UltraCruz Hand Sanitizing Gel Santa Cruz Biotechnology, Inc. Antimicrobial 3 FLUID OZ/89 ML (2) 237 ml NDC: 90032-214-08 UltraCruz Hand Sanitizing Gel Santa Cruz Biotechnology, Inc. Antimicrobial 8 FLUID OZ/237 ML (3) 3.8 L NDC: 90032-214-94 UltraCruz Hand Sanitizing Gel Santa Cruz Biotechnology, Inc. Antimicrobial 1 GALLON (3.8 L) ACTIVE INGREDIENT(S) 70% Isopropyl Alcohol. Purpose: Antimicrobial PURPOS E Antimicrobial US E Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use. WARNINGS Flammable. Keep away from open flame. For external use on the hands only. Avoid contact with eyes. If eye contact occurs, flush with water. Stop and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, seek medical help or contact Poison Control immediately. Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. DIRECTIONS Place a palmful of product in one hand. Spread on both hands and rub into the skin until dry. Children under 6 years of age should be supervised when using. OTHER INFORMATION Store below 110F (43C) May discolor fabrics or surfaces Read the complete document