Active Ingredient
Active Ingredient Purpose
Ethyl Alcohol 62%（V/V） Antiseptic
Mellow Hand Sanitizer 500ml Ml308-prp
FDA Label NDC 54860-331
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Lantern Scicence Co.,ltd. for the product Mellow Hand Sanitizer 500ml Ml308-prp (NDC 54860-331). 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 drug facts, active ingredient, use, do not use, dosage & administration, warning, warnings and precautions, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.
Do Not Use
In children less than 2 months of age.
On open skin wounds.
In children less than 2 months of age.
On open skin wounds
Dosage & Administration
Recommended for repeated use.
use anywhere without water.
Warning
For extenal use only:hands.
Flammable,Keep away from fire or flame.
Warnings And Precautions
For external use only.
Flammable, keep away from heat and flame.
Otc - Stop Use
Discontinue if skin becomes irritated and ask a doctor .
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poson control center immediately.
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.
Inactive Ingredients
Alcohol，water，Isopropyl Alcohol，Glycerin，Carbomer，Aminomethyl Propanol，Parfum，Propylene Glycol，ISOPROPYL MYRISTATE，ALOE BARBADENSIS LEAF JUICE，Tocopheryl Acetate，YELLOW No.5，FD&C BLUE No. 1.
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.
Otc - Do Not Use
When using this product
keep out of eyes. In case of contact with eyes, flush thoroughly with water.
Do not inhale or ingest.
Avoid contact with broken skin.
Other Information
Do not store above 105F.
May discolor some fabrics.
Harmful to wood finishes and plastics.
Store between 15-30C
Avoid freezing and excessive heat above 40C
* Please review the disclaimer below.
