Active Ingredient(S)
Ethyl Alcohol 61% v/v. Purpose: Antimicrobal
Hand Sanitizer Gel
FDA Label NDC 77183-8067
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tekna Fill, Inc. for the product Hand Sanitizer Gel (NDC 77183-8067). 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
Antimicrobial, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria and viruses on the skin which could cause illness or disease. Recommended for repeated use.
Warnings
Flammable. Keep away from heat or flame.
For external use only
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if redness or irritation occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Apply enitre package contents onto hands and rub until dry.
- Children under 6 years of age should be supervised when using this product.
Other Information
- Store below 110 degrees F (43 degrees C)
- May discolor certain fabrics or surfaces
- www.ViRlogix.com
Inactive Ingredients
Purified Water, Glycerol, Carbomer 940, Hydrogen Peroxide, Trolamine, Eucalyptus Oil
Recent Major Changes
Warnings:
Flammable. Keep away from fire or flame.
For external use only
When using the product do not use in or near the eyes. In case of contact, rinse eyes thoroughtly with water.
Stop use and consult a doctor if redness or irritation occurs.
Keep out of reach of children. If swallowed, get medical helpor contact a Poison Control Center immediately.
Use:
Hand sanitizer to help reduce bacteria and viruses on the skin which could cause illness or disease
Recommeded for repeated use
Directions:
Apply entire package contents onto hands and rub until dry
Children under 6 years of age should be supervised when using this product
Package Label - Principal Display Panel
NDC: 77183-8067-1
24 PACKETS in 1 BOX > 2.5mL in 1 PACKET
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