Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 81650-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skymax Vietnam Company Limited for the product Hand Sanitizer (NDC 81650-100). 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
Recommended for repeated use.
For handwashing to decrease bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in the eyes. In case of contact, rinse eyes thoroughly with water
Otc - When Using
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 right away.
Directions
- We hands thoroughly with product
- Brisky rub hands together until dry
- Supervise children under 6 years in the use of this product.
Other Information
- May discolor certain fabrics
- Store at the normal temperature
Inactive Ingredients
aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e
Recent Major Changes
Indications and Usage: Change wordings
Directions: Change wordings
Package Label - Principal Display Panel
100 mL NDC: 81650-100- 01
250 mL NDC: 81650-100- 02
500 mL NDC: 81650-100- 03
1000 mL NDC: 81650-100- 04
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