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This is a gel hand sanitizer manufactured using only United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.
Hand Sanitizer
FDA Label NDC 79027-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Savvy Wellness for the product Hand Sanitizer (NDC 79027-001). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Alcohol 80% v/v.
Purpose
Antiseptic
Use
Hand rub to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
In children less than 2 months of age and on open skin wound.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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
- 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
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Purified water USP, PEG 300, aloe vera, hydroxyethyl cellulose, sodium hydroxide, tocopheral acetate, cassia bark oil, lavender oil, tea tree oil, lemon peel oil.
Package Label - Principal Display Panel
1.25 mL NDC: 79027-001-01
* Please review the disclaimer below.
