Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Hand Sanitizer Gel
FDA Label NDC 10079-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Homelike Inc for the product Hand Sanitizer Gel (NDC 10079-500). 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(s), purpose, 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.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
To decrease bacteria on the skin that could cause disease.
Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
keep out of eyes. In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin.
do not inhale or ingest.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops.
condition persists for more than 72 hours.
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
- 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.
Other Information
- Do not store above 105F
- May discolor some fabrics.
- Harmful to wood finishes and plastics.
Inactive Ingredients
AMINOMETHYLPROPANOL ,CARBOMER,GLYCERIN ,PROPYLENE GLYCOL, WATER
Package Label - Principal Display Panel
500 ml in 1 BOTTLE NDC:10079-500-01
500 mL Label (500ml)
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