Purpose
PURPOSE: ANTIMICROBIAL
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Baihua Co., Ltd. for the product Alcohol Wipes (NDC 77665-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, active ingredient(s), use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
PURPOSE: ANTIMICROBIAL
ACTIVE INGREDIENT: ETHYL ALCOHOL 75%
USES: HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.
WARNINGS: FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME
■ FOR EXTERNAL USE ONLY.
■ DO NOT USE IN OR NEAR THE EYES.
IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.
■ STOP USE AND CONSULT WITH A PHYSICIAN IF IRRITATION DEVELOPS AND LASTS FOR MORE THAN 72 HOURS.
■ KEEP OUT OF REACH OF CHILDREN.
■ IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
■ DO NOT USE IN OR NEAR THE EYES.
IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.
■ IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
■ STOP USE AND CONSULT WITH A PHYSICIAN IF IRRITATION DEVELOPS AND LASTS FOR MORE THAN 72 HOURS
■ KEEP OUT OF REACH OF CHILDREN
■ DISPENSING. LIFT THE FRONT LID. OPEN PROTECTIVE SEAL. PULL OUT WIPE, RESEAL, AND CLOSE THE LID.
■ USE. WIPE HANDS THOROUGHLY.
■ DISPOSAL. DO NOT FLUSH.
Directions of Use:
1. Open the lid and slowly peel back label.2. Pull out wipes as needed.
3. Reseal label to retain moisture.
STORAGE. STORE AT ROOM TEMPERATURE.
Glycerol, Hydrogen Peroxide, RO pure water
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