Active Ingredient
ETHYL ALCOHOL 70%
Bak-off Hand Sanitizer
FDA Label NDC 50518-305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Custom Research Labs Inc for the product Bak-off Hand Sanitizer (NDC 50518-305). 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 active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTISEPTIC
Uses
TO DECREASE BACTERIA ON THE SKIN
RECOMMENDED FOR REPEATED USE
Warnings
FOR EXTERNAL USE ONLY (HANDS).
FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.
WHEN USING THIS PRODUCT
- KEEP OUT OF EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
- AVOID CONTACT WITH BROKEN SKIN
- DO NOT INHALE OR INHEST
- IRRITATION AND REDNESS DEVELOP
- CONDITION PERSISTS FOR MORE THAN 72 HOURS
STOP USE AND ASK A DOCTOR IF
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Directions
WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING
- FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION
- NOT RECOMMENDED FOR INFANTS
Other Information
DO NOT STORE ABOVE 105°F
- MAY DISCOLOR SOME FABRICS
- HARMFUL TO WOOD FINISHES AND PLASTICS
Inactive Ingredients
WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, ISOPROPYL MYRISTATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL, CARBOMER, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL
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